Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals | FDA

Coronavirus Disease 2019 (COVID-19) Resources for Health Professionals | FDA

Updates June 4, 2020 - Daily Roundup June 4, 2020 - Visit our “At-A-Glance” Resource Summarizing the FDA COVID-19 Response June 4, 2020 - FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study June 4, 2020 - An Introduction to COVID-19 Tests - New Video Posted! June 3, 2020 - Daily Roundup June 1, 2020 - Federal Judge Enters Order of Permanent Injunction Against New York Company for Distributing Unapproved Drugs Stay up to date on Coronavirus Disease 2019 (COVID-19) by visiting the Resources for Health Professionals page. Resources for HP

Request for Comments June 4, 2020 - Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency : The purpose of this guidance is to state the current intent of the Food and Drug Administration (FDA, we, or the Agency), in certain circumstances related to the impact of the coronavirus outbreak (COVID-19), not to enforce requirements in three foods regulations to conduct onsite audits of food suppliers if other supplier verification methods are used instead. June 2, 2020 - Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators : FDA is issuing this guidance to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19. June 1, 2020 - CVM GFI #240 Proprietary Names for New Animal Drugs : This guidance provides recommendations to help new animal drug sponsors (you) develop proprietary names that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This guidance provides a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine (CVM or we). June 1, 2020 - FDA Requests Input on the Establishment of a Rare Disease Clinical Trial Network : The FDA is announcing the establishment of a docket to obtain information and comments from patients, patient advocates, the scientific community, health professionals, other regulatory and health authorities in the global community, regulated industry, and the general public regarding practical steps and successful approaches to establish a rare disease clinical trials network. For a more comprehensive list of all official FDA Guidance Documents and other regulatory guidances, please visit here.

FDA Voices Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response In March, we were a few days away from announcing the release of the New Era of Smarter Food Safety Blueprint when the FDA’s focus turned to the COVID-19 pandemic. Our plans for the New Era initiative were rightfully put on hold in order to prioritize the agency’s COVID-19 response. As a public health agency, we will always prioritize any threat to the health of the American people. The FDA will release the blueprint in the coming weeks, outlining our plans over the next decade to create a more digital, traceable, and safer food system. The challenges that have arisen during the pandemic have made it clear that the actions called for in the blueprint will strengthen how we approach the safety and security of the food supply, not just in the normal course of events but especially in times of crisis.

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Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Pandemic By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs (pictured below) In hospitals all across this country, doctors continue to deal with the influx of COVID-19 cases. As a doctor, my heart breaks for the patients and their families. I also want to express admiration for my peers in the medical community who are doing everything they can to treat patients ill with this novel disease that we continue to learn about every day.

At the FDA, our public health concern is for the American people, and much like the health care professionals on the frontlines, our team of 18,000 strong are using their years of expertise to make decisions based on the best science and data at hand during this unparalleled public health emergency. One area where there’s been tremendous public interest is potential prevention and treatment options.

The FDA plays a pivotal role in this work to both help move new medical products to patients as soon as possible, while at the same time determine whether they are effective and if the benefits outweigh the risks. Continue Reading

Public Meetings and Workshops

Webcast - Regulatory Education for Industry (REdI): Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies This training is designed to provide participants with a foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug and biological products.  Date: June 9, 2020      Time: 9:00 AM - 4:35 PM ET Date: June 10, 2020    Time: 9:00 AM - 3:35 PM ET To register for this training, please visit the registration page.

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Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests The 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. Date: June 10, 2020    Time: 12:15 PM - 1:15 PM ET Registration is not necessary.

Webcast - A Pandemic and a Call to Action for One Health: The FDA One Health Initiative One Health is a concept that embraces a multisectoral and transdisciplinary approach to solving health problems by recognizing the interconnection between humans, animals, and their shared environment. Many global changes and activities associated with increased human-animal interactions are enabling disease transmission that become epidemics or pandemics that adversely impact public health. This presentation will explain the One Health Concept and the FDA One Health Initiative. It will also highlight the benefits of One Health and how FDA is operationalizing One Health actions Agency-wide. Date: June 11, 2020    Time: 12:00 PM - 1:00 PM ET To register for this webcast, please visit the registration page.

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Recall and Safety Information Two Neuromuscular Blocking Agents: CDER Alert - FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents, vecuronium bromide for injection, 10 mg and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL and 100 mg/10 mL vials. [June 3, 2020] Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert - FDA Alerts Patients and Health Care Professionals About Device Malfunction FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.  If the auto-injector is missing the yellow “stop collar” component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient. [June 1, 2020]

The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients To protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants, the FDA requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market. [June 1, 2020]

Consumer Updates

Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19 There are no FDA-approved coronavirus preventions or treatments. Researchers are studying new drugs, and drugs approved for other conditions, as possible preventions or treatments for COVID-19. The language describing possible preventions or treatments can be confusing. Here’s what those terms mean.

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