INTRODUCTION:

COVID - 19 pandemic is Corona virus disease 2019, is a infectious viral disease caused by severe acute respiratory syndrome Coronavirus 2 which is first identified in wuhan, China in December 2019. On December 31 2019 Wuhan Municipal Health Commission, China reported WHO about multiple cases of pneumonia in Wuhan Hubei Province. A novel coronavirus was eventually identified. On January 30 2020 the World Health Organization declared a public health emergency of international concern and a pandemic on March 11 2019^[1]. As of today more than 3.82 million cases have been reported through out the world, with US, Spain and Italy in first three places of highest cases reported^[2]. Most of the people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring any special treatment.

Older people, and people with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness. The best way to prevent and slow down transmission is be well informed about the COVID-19 virus, the disease it causes and how it spreads. Protect yourself and others from infection by washing your hands or using an alcohol based rub frequently and not touching your face^[3].

The Coronavirus spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, so it’s important that you also practice respiratory etiquette (for example, by coughing into a flexed elbow). At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments^[3].

FDA UPDATES:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products^[4].

FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens (8 MAY 2020) ^[5]:

· The U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously authorized under the high complexity molecular-based LDT “umbrella” EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. This announcement builds on last month’s EUA for the first diagnostic test with a home-collection option, which uses a sample collected from the patient’s nose with a nasal swab and saline.

· FDA issued two documents designed to assist retail food establishments that might have been closed or partially closed during the COVID-19 pandemic in preparing to reopen. The checklist and infographic documents are designed to help businesses that prepare food to serve or sell to the public directly, such as restaurants, bakeries, bars and carry-outs, protect employee and public health as they reopen for business.

· The FDA issued an updated At-A-Glance that provides a quick look at facts, figures and highlights of agency’s response efforts.

· The FDA and Federal Trade Commission (FTC) issued warning letters to four companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

· The first seller warned, Sanit Technologies LLC dba Durisan, offers non-alcohol based hand sanitizer products for sale in the U.S. with false or misleading claims including that the products maintain their effectiveness for up to 24 hours. Such time-specific extended efficacy claims may give users the false impression that they need not rigorously adhere to interventions such as social distancing and exercising good hygienic practices that have been demonstrated to curb the spread of COVID-19.

· The second seller warned, AgroTerra, Ltd. Dba Patriot Hemp Company, offers CBD products for sale U.S. with misleading claims that the products are safe and/or effective for the prevention of COVID-19. In addition, FDA observed that the company participates in the Amazon Associates program. In the program, the company earns commissions by promoting the sale of multiple products on the company’s website with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people.

· The third seller warned, Washing tons Last Frontier.Com, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of products, including essential oils and dietary supplements, on the company’s website with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people.

· The fourth seller warned, Chronic Lyme Treatments, offers herbal products for sale in the U.S. that misleadingly represent the products as safe and/or effective for the prevention and/or treatment of COVID-19.

FDA Continues to Combat Fraudulent COVID-19 Medical Products (7 MAY 2020)^[6]:

· The U.S. Food and Drug Administration is providing an update on the agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic. In response to scammers on the internet selling unproven medical products, the FDA has taken – and continues to take – a number of steps to find and stop those selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19.

· “While FDA ensure access to critical medical products, it is imperative that FDA continue their efforts to find and prevent the sale and distribution of products that may be harmful to the public health. Americans can rest assured that we’re leveraging our experience investigating, examining, and reviewing medical products, both at the border and within domestic commerce, to help ensure that the critical resources reaching the frontlines in the battle against COVID-19 are appropriate,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D. “We take seriously our responsibility to determine whether the medical products coming into our country are fraudulent, counterfeit or illegitimate, and take action as needed.”

· To date, the FDA has issued 42 warning letters to companies making bogus COVID-19 claims, including one to a seller of fraudulent chlorine dioxide products, equivalent to industrial bleach, frequently referred to as “Miracle Mineral Solution” or “MMS”, as a treatment for COVID-19. After the seller refused to take corrective action, a federal court issued a preliminary injunction requiring the seller to immediately stop distributing its unproven and potentially dangerous product.

· Additionally, as part of the FDA’s Operation Quack Hack, in just a few short weeks, the agency has discovered hundreds of such products including fraudulent drugs, testing kits and personal protective equipment (PPE) sold online with unproven claims. FDA continue to work with online marketplaces, domain name registrars, payment processors and social media websites to remove from their platforms products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19 and to keep those products from reappearing under different names. At this time, the FDA has sent hundreds of abuse complaints to domain name registrars and internet marketplaces, who in most instances, have voluntarily removed the identified postings. The agency will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. The agency encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA.

· There are a number of examples of unproven products that the FDA is keeping out of the country. Recently, the agency intercepted and investigated a case of mislabeled COVID-19 “treatment kits” offered for import. As a result, Special Agents with the FDA’s Office of Criminal Investigations, with the help of domestic and international law enforcement counterparts in the United Kingdom, led the Department of Justice to bring a criminal complaint against a British man who sought to profit from this pandemic and jeopardize public health.

· Until the curve is flattened, and even after, the FDA will continue to carry out the agency’s mission of protecting the health and safety of American consumers and strive to prevent unlawful FDA-regulated products from entering, or being distributed in, domestic commerce.

FDA actions on device manufacturing guidance, diagnostics and more in its ongoing response to the COVID-19 pandemic (6 MAY 2020)^[7]:

· The FDA issued an immediately in effect guidance Notifying the Center for Devices and Radiological Health of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act During the COVID-19 Public Health Emergency. This guidance is intended to assist manufacturers in providing FDA timely, informative notifications about changes in the production of certain medical device products that will help the Agency prevent or mitigate shortages of such devices during the COVID-19 public health emergency. On May 11, 2020, the FDA will host a webinar for medical device manufacturers and others interested in learning more about the guidance.

· Diagnostics update to date:

During the COVID-19 pandemic, the FDA has worked with more than 385 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.

To date, the FDA has issued 60 individual EUAs for test kit manufacturers and laboratories. In addition, 25 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).

The FDA has been notified that more than 240 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

FDA actions on warning letters, generic drug approvals and more in its ongoing response to the COVID-19 pandemic (5 MAY 2020)^[8]:

· The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

· The first seller warned, Honey Colony LLC, offers products including “Quicksilver Liposomal Vitamin C w/ Liposomal,” “Jigsaw Magnesium With SRT,” and products labeled to contain silver, including “Silver Excelsior Serum”, for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.

· The second seller warned, Dr. Dhole’s Sushanti Homeopathy Clinic, offers products including “Homeopathic Genus Epidemicus” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention of COVID-19

Approval of Generic Drugs (4 MAY 2020)^[8]:

FDA approved two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation: succinylcholine chloride injection USP 200mg/10mL and cisatracurium besylate injection USP 20mg/10mL. FDA recognizes the increased demand for certain products during the novel coronavirus pandemic and the agency remain deeply committed to facilitating access to medical products to help address critical needs of the American public.

FDA actions on an updated serology policy, warning letters and more in its ongoing response to the COVID-19 pandemic (4 MAY 2020)^[9]:

· A new FDA Voices, Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy, explains today’s update to a policy from March 16, 2020 on antibody tests for COVID-19. The FDA will continue to take steps to appropriately balance assurances that an antibody test is accurate and reliable with timely access to such tests as the continually evolving circumstances and public health needs warrant.

· FDA issued warning letters to operators of two websites, www.antroids.com and www.foxroids.com, that market unapproved COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved drugs to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. Consumers can visit BeSafeRx to learn about how to safely buy medicine online.

Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy (4 MAY 2020)^[10].:

The FDA announced important updates to our March 16, 2020 policy on commercial manufacturers’ serology—or antibody—tests for #COVID19. Under the new policy, FDA expects commercial manufacturers to submit Emergency Use Authorization (EUA) requests, including their validation data, within 10 days of the updated policy publication date, or the date they notify FDA of their test validation, whichever is later.

FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment (1 MAY 2020)^[11].:

· U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

· While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.

FDA actions on new EUAs including an innovative ventilator developed in partnership with NASA, consumer update on pets, drug supply guidance and more in its ongoing response to the COVID-19 pandemic (30 APRIL 2020)^[12]:

The FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic.

Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets (30 APRIL 2020)^[13]:

You have probably seen and heard a lot about the coronavirus (COVID-19) and how to keep you and your family safe. But what about the other, furrier members of the family, your pets? Below, the U.S. Food and Drug Administration offers some questions and answers to help keep you, your family, and your pets safe during the pandemic.

Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency (30 APRIL 2020)^[14]:

FDA will discuss the challenges of, and guidance for, supporting clinical trials during the COVID-19 public health emergency. Note: This webinar is now full, but the recording of the webinar will be available shortly after the webinar concludes.

Tips on Good Nutrition and Using the Updated Nutrition Facts Label During the Coronavirus Pandemic (29 APRIL 2020)^[15]:

The newly updated Nutrition Facts Label can help you and your family eat healthy when daily routines change. Take a look at these new features:

· Calories are now displayed in larger, bolder font.

· Some serving sizes have been updated to better reflect what people actually eat and drink.

· Added sugars, vitamin D and potassium are now listed.

· Daily values have been updated. The percent Daily Value (%DV) shows how much a nutrient in a serving of food contributes to a total daily diet.

FDA actions on warning letters, video resources on EUAs and more in its ongoing response to the COVID-19 pandemic (28 APRIL 2020)^[16]:

· The first seller warned, Hopewell Essential Oils, offers essential oils and herbal products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.

· The second seller warned, Santiste Labs LLC, the “DefendTM Patch,” a transdermal patch containing a “composition of botanical oils,” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention or treatment of COVID-19.

· The FDA issued a new video resource. explaining Emergency Use Authorizations (EUAs), one of several tools FDA uses to help make important medical products available quickly during public health emergencies like the COVID-19 pandemic, explains, EUAs provide more timely access to drugs, diagnostic tests and/or other critical medical products that can help diagnose, treat and/or prevent COVID-19. When deciding whether to issue an EUA, the FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public.

FDA actions on hand sanitizer safety information, food production fact sheets and more in its ongoing response to the COVID-19 pandemic (27 APRIL 2020)^[17]:

The FDA issued a statement, “Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Address Safety Concerns,” to discuss the Agency’s efforts to increase availability of alcohol-based hand sanitizer and the importance of making hand sanitizer unpalatable to people, including children, through the use of denatured alcohol. Calls to the National Poison Data System last month related to hand sanitizer increased by 79 percent compared to March 2019, with the majority of these calls accounting for unintentional exposures in children 5 years of age and younger. The statement also warns consumers about hand sanitizer sold with fraudulent claims.

FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems (23 APRIL 2020)^[18]:

U.S. Food and Drug Administration issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19.

Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests (22 APRIL 2020)^[19]:

· The objective is to answer technical questions about the development and validation of tests for SARS-CoV-2.

· On May 13, 2020, from 12:15 pm - 1:15 pm Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.

· The FDA also plans to hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on the following dates:

May 20, 2020 from 12:15 pm – 1:15 pm Eastern Time.

May 27, 2020 from 12:15 pm – 1:15 pm Eastern Time.

FDA actions on remote monitoring EUAs, warning letters on fraudulent products and more in its ongoing response to the COVID-19 pandemic (22 APRIL 2020)^[20]:

· The FDA issued an emergency use authorization (EUA) for the Philips Medizin Systeme Boeblingen GmbH's IntelliVue Patient Monitors MX750/MX850, IntelliVue 4-Slot Module Rack FMX-4 and IntelliVue Active Displays AD75/AD85, intended to be used by healthcare professionals in the hospital environment for remote monitoring of adult, pediatric and neonate patients having or suspected of having COVID-19 to reduce healthcare provider exposure. The IntelliVue Patient Monitors are not intended for home use. The remote monitoring capabilities of the Philips IntelliVue Patient Monitors reduce the amount of contact by healthcare providers with patients during the COVID-19 pandemic who are in isolation rooms, thereby reducing the healthcare providers' risk of exposure to the virus.

· The FDA and Federal Trade Commission issued a warning letter to a seller of fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Copper Touch, LLC, offers unapproved and misbranded products including “Sani-Bar GK95” and “Sani-Disc GK95D” for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

· The FDA issued a guidance explaining a temporary policy regarding the repackaging or combining of FDA-approved propofol injectable emulsion, 10 mg/ mL (propofol) products, for the treatment or management of hospitalized patients during the COVID-19 public health emergency. This guidance provides regulatory flexibility for state-licensed pharmacies (including hospital pharmacies), federal facilities and outsourcing facilities that repackage or combine FDA-approved propofol products for hospitals that are having difficulty obtaining adequate supplies of the FDA-approved version in the sizes they use to support or treat patients with COVID-19.

FDA Provides Flexibility to the Food Industry to Support Food Supply Chain and Meet Consumer Demand During COVID-19 and FDA actions on the first diagnostic test with an at-home sample collection options (21 APRIL 2020):

· The FDA is working closely with the food industry and USDA to provide flexibility regarding federal food labeling so consumers have access to the food they want^[21].

· The FDA authorized the first diagnostic test with an at-home sample collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit. Today’s reissued EUA permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. After patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks^[22].

The Path Forward: Coronavirus Treatment Acceleration Program (20 APRIL 2020)^[23]:

The FDA has launched a new program called the Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as soon as possible, while at the same time finding out whether they are helpful or harmful.

Serological Test Validation and Education Efforts (18 APRIL 2020)^[24]:

FDA says about, serological tests that are currently on the market, and their significance in the nation’s response efforts, we’d like to provide further details about our thinking on these tests and our approach to making accurate and reliable serology tests widely available, while also protecting Americans from tests marketed with false or unsubstantiated claims.

FDA actions on vaccine public-private partnerships, warning letters, EUAs and more in its ongoing response to the COVID-19 pandemic (17 APRIL 2020)^[25]:

● NIH announced a public-private partnership with the FDA and others to speed the development of COVID-19 vaccine and treatment options. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership also includes the U.S. Centers for Disease Control and Prevention, the European Medicines Agency, the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, as well as more than a dozen biopharmaceutical companies.

● A federal court has entered a temporary injunction against the Genesis II Church of Health and Healing (Genesis) and four individuals associated with the entity requiring them to immediately stop distributing its “Miracle Mineral Solution” (MMS), an unproven and potentially harmful treatment offered for sale to treat Coronavirus, which includes Coronavirus Disease 2019 (COVID-19) and many other diseases. The FDA, jointly with the Federal Trade Commission (FTC), previously issued a warning letter to Genesis and the FDA has warned consumers numerous times over the past decade not to purchase or drink chlorine dioxide products such as MMS sold as medical treatments. The FDA and FTC requested that the company respond within 48 hours describing the specific steps it has taken to correct the violations. In response to the warning letter, the defendants made clear that they had no intention of taking corrective action and would continue to sell MMS in violation of the law.

FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies (17 APRIL 2020)^[26]:

· The FDA is providing an update on one potential treatment called convalescent plasma and encouraging those who have recovered from COVID-19 to donate plasma to help others fight this disease.

· Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. It is important that we evaluate this potential therapy in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients, as appropriate.

Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Decontaminate Millions of N95 Respirators (12 APRIL 2020)^[27]:

The FDA issued an emergency use authorization (EUA) that has the potential to decontaminate approximately 4 million N95 or N95-equivalent respirators per day in the U.S. for reuse by health care workers in hospital settings.

FDA Authorizes Blood Purification Device to Treat COVID-19 (10 APRIL 2020)^[28]:

The FDA issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19 (3 APRIL 2020)^[29]:

The FDA is taking the lead on a national effort to facilitate the development of, and access to, two investigational therapies derived from human blood. These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus.

FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic (2 APRIL 2020)^[30]:

The FDA issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components.

FDA Continues to Accelerate Development of Novel Therapies for COVID-19 (31 MARCH 2020)^[31]:

The FDA stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.

FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation (30 MARCH 2020) ^[32]:

The law grants the FDA transformative, new authorities that will meaningfully advance our efforts to modernize the OTC drug development and review process to help advance innovative, safe and effective options for consumers and secure a robust OTC marketplace.

FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 Response Public-Private Partnership (25 MARCH 2020)^[33]:

The FDA entered a Memorandum of Understanding (MOU) with the VA Innovation Ecosystem and the NIH 3D Print Exchange, to share data and coordinate on open-source medical products for the COVID-19 response. These agencies are also working closely with America Makes to provide resources that will connect health care providers and 3D printing organizations.

FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits (20 MARCH 2020) ^[34]:

The FDA is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.

FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health (20 MARCH 2020)^[35]:

As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19 (9 MARCH 2020)^[36]:

· The FDA and the Federal Trade Commission issued warning letters to seven companies for selling fraudulent COVID-19 products. These products are unapproved drugs that pose significant risks to patient health and violate federal law. The FDA and FTC are taking this action as part of their response in protecting Americans during the global COVID-19 outbreak.

· The FDA and FTC jointly issued warning letters to Vital Silver, Quinessence Aromatherapy Ltd., Xephyr, LLC doing business as N-Ergetics, GuruNanda, LLC, Vivify Holistic Clinic, Herbal Amy LLC, and The Jim Bakker Show.

FDA and CDC take action to increase access to respirators, including N95s, for health care personnel (9 MARCH 2020)^[37]:

In a joint effort, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. Today’s action allows certain National Institute for Occupational Safety and Health (NIOSH) approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.

FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic (4 FEBRUARY 2020)^[38]:

FDA issued an EUA to enable broader emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.

FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures (4 FEBRUARY 2020)^[39]:

“We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged in Wuhan, China,” said FDA Commissioner Stephen M. Hahn, M.D. “We are actively leveraging the vast breadth of the FDA’s expertise and have begun employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.”

TAKE AWAY POINTS:

· Announcement of key actions by FDA

· Introducing Emergency Use Authorization by FDA

· Action to make more respirators including N95s.

· Warning letters to companies selling fraudulent products or unapproved products.

· Warning consumers about unauthorized, unapproved and fraudulent products.

· Signing of emergency relief bill.

· Introducing coronavirus treatment acceleration Program (CTAP)

· Leading investigational therapies such as convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus.

· Encouraging recovered patients to donate Plasma for Development of Blood-Related Therapies.

· Focusing on nutrition tips.

· Conducting webinars with a focus on clinical trials.

· Helping people by offering question and answers.

· Approval of generic drugs.

· Updating Diagnostics to date after working with 386 test developers.

· Manufacturing guidance for diagnostics, and alcohol made sanitizers.

· hosting virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.

CONCLUSION:

FDA is concerned with international human and veterinary health, it is working actively and effectively in all aspects with its nation and other international regulatory agencies to mitigate the impact of novel Coronavirus. It is also warning consumers regarding usage of fraudulent products but the consumers are not much worried as FDA do for them. Like FDA, other international agencies are working to mitigate impact of covid 19 pandemic to save human and veterinary life. Let us stand with regulatory agencies by kicking out fraudulent news and products.

REFERENCES:

1. WHO - timeline - covid-19 https://www.who.int/news-room/detail/ 27-04-2020-who-timeline---covid

2. Information on COVID 19, the infectious disease caused by the most recently discovered Coronavirus. www.who.int https:// www.who.int/emergencies/diseases/novel-coronavirus-2019

3. Coronavirus www.who.int https://www.who.int/health-topics/ coronavirus#tab=tab_1

4. Coronavirus (COVID-19) Update: Daily Roundup. www.fda.gov/ news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-8-2020.

5. Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens. https://www.fda.gov/news-events/press-announcements/ coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-using-home-collection-saliva

6. Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products. https://www.fda.gov/ news-events/press-announcements/ coronavirus-covid-19-update-fda-continues-combat-fraudulent-covid-19-medical-products

7. Coronavirus (COVID-19) Update: Daily Roundup. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-6-2020

8. Coronavirus (COVID-19) Update: Daily Roundup. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-5-2020

9. Coronavirus (COVID-19) Update: Daily Roundup https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-4-2020

10. Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy. https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accura

11. Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment

12. Coronavirus (COVID-19) Update: Daily Roundup. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-30-2020

13. Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets. https://www.fda.gov/consumers/consumer-updates/helpful-questions-and-answers-about-coronavirus-covid-19-and-your-pets

14. Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency. https://www.fda.gov/drugs/news-events-human-drugs/sbia-webinar-conducting-clinical-trials-during-covid-19-public-health-emergency-04302020-04302020

15. Tips on Good Nutrition and Using the Updated Nutrition Facts Label During the Coronavirus Pandemic. https://www.fda.gov/ consumers/consumer-updates/tips-good-nutrition-and-using-updated-nutrition-facts-label-during-coronavirus-pandemic

16. Coronavirus (COVID-19) Update: Daily Roundup. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-28-2020

17. Coronavirus (COVID-19) Update: Daily Roundup. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-27-2020

18. Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems. https://www.fda.gov/news-events/press-announcements/ coronavirus-covid-19-update-fda-reiterates-importance-close-patient-supervision-label-use

19. Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests. https://www.fda.gov/ medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-immediately-effect-guidance-coronavirus-covid-19-diagnostic-tests-05132020

20. Coronavirus (COVID-19) Update: Daily Roundup. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-22-2020

21. FDA Provides Flexibility to the Food Industry to Support Food Supply Chain and Meet Consumer Demand During COVID-19. https://www.fda.gov/news-events/fda-voices/fda-provides-flexibility-food-industry-support-food-supply-chain-and-meet-consumer-demand-during

22. Coronavirus (COVID-19) Update: Daily Roundup. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-21-2020

23. The Path Forward: Coronavirus Treatment Acceleration Program https://www.fda.gov/news-events/fda-voices/path-forward-coronavirus-treatment-acceleration-program

24. Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-education-efforts

25. Coronavirus (COVID-19) Update: Daily Roundup. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-17-2020

26. FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies. https://www.fda.gov/ news-events/press-announcements/coronavirus-covid-19-update-fda-encourages-recovered-patients-donate-plasma-development-blood

27. Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Decontaminate Millions of N95 Respirators https://www.fda.gov/news-events/press-announcements/ coronavirus-covid-19-update-fda-issues-emergency-use-authorization-decontaminate-millions-n95

28. Coronavirus (COVID-19) Update:FDA Authorizes Blood Purification Device to Treat COVID-19 https://www.fda.gov/ news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-blood-purification-device-treat-covid-19

29. Coronavirus (COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related Therapies for COVID-19 https://www.fda.gov/news-events/press-announcements/ coronavirus-covid-19-update-fda-coordinates-national-effort-develop-blood-related-therapies-covid-19

30. Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic. https://www.fda.gov/news-events/press-announcements /coronavirus-covid-19-update-fda-provides-updated-guidance-address-urgent-need-blood-during-pandemic

31. Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19

32. FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation. https://www.fda.gov/news-events/press-announcements/fda-signing-covid-19-emergency-relief-bill-including-landmark-over-counter-drug-reform-and-user-fee

33. FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 Response Public-Private Partnership. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/fda-efforts-connect-manufacturers-and-health-care-entities-fda-department-veterans-affairs-national

34. Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits. https:// www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-alerts-consumers-about-unauthorized-fraudulent-covid-19-test-kits

35. Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-guidance-production-alcohol-based-hand-sanitizer-help-boost

36. Coronavirus Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products that Claim to Treat or Prevent COVID-19. https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-and-ftc-warn-seven-companies-selling-fraudulent-products-claim-treat-or

37. Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to respirators, including N95s, for health care personnel. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s

38. FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization (EUA) for the First 2019 Novel Coronavirus Diagnostic. https://www.fda.gov/news-events/ press-announcements/fda-takes-significant-step-coronavirus-response-efforts-issues-emergency-use-authorization-first

39. FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures https://www.fda.gov/news-events/press-announcements/fda-announces-key-actions-advance-development-novel-coronavirus-medical-countermeasures

Received on 10.05.2020 Modified on 12.06.2020

Asian J. Res. Pharm. Sci. 2020; 10(4):273-281.

DOI: 10.5958/2231-5659.2020.00048.X