FDA Stakeholder Update - March 20, 2020

Dear Colleague,

FDA's Stakeholder Engagement Staff works to provide you with up-to-date information to further our commitment to advance public health and well-being.

Coronavirus Disease 2019 (COVID-19)

Announcements

• March 20, 2020 - FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health
• March 20, 2020 - FDA allows expanded use of devices to monitor patients’ vital signs remotely
• March 19, 2020 - FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19
• March 19, 2020 - FDA Continues to Facilitate Development of Treatments
• March 19, 2020 - Blood Donations
• March 19, 2020 -  Coronavirus (COVID-19) Frequently Asked Questions has now been translated into Spanish
• March 18, 2020 - FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections

Draft and Final Guidances

• March 19, 2020 - Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
• March 19, 2020 - Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
• March 18, 2020 - FDA Issues Guidance for Conducting Clinical Trials
• March 17, 2020 - Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency

Drug Shortages The FDA continues to take steps to monitor the supply chain.  The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms, and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak.  For the latest information from the FDA on COVID-19 see our website at: Coronavirus Disease 2019 (COVID-19). To report a drug shortage, please contact the CDER Drug Shortage Staff below

Report a Drug Shortage

FDA Announcements

FDA requires new health warnings for cigarette packages and advertisements The FDA issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements. The warnings feature textual statements with photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, diabetes and more. [03/17/2020] FDA Finalizes Guidance for Industry on Applications for Drugs with Inadequate Generic Competition The FDA finalized guidance for industry, “Competitive Generic Therapies” (CGTs), which describes the process that generic drug applicants should follow to request designation of a drug as a CGT and the criteria for that designation. The final guidance provides information on actions the FDA may take to expedite development and review of Abbreviated New Drug Applications (ANDAs) for drugs designated as CGTs and explains how the FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first-approved applicants who submit ANDAs for CGTs. [03/13/2020]

FDA Guidance Document

Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry by May 18, 2020

This guidance provides recommendations regarding the use of restricted delivery systems, to limit unintentional ingestion of oral liquid drug products (e.g., oral solution, oral suspension) by children. The recommendations in this guidance apply broadly to oral liquid drug and biological products. Accordingly, this guidance is intended for manufacturers of oral liquid drug and biological products.

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Consumer Updates

Where and How to Dispose of Unused Medicines

Is your medicine cabinet full of expired drugs or medications you no longer use? Your medicine is for you. What’s safe for you might be harmful for someone else. You can dispose of your expired, unwanted, or unused medicines through a drug take back program — or you can do it at home Drug Take Back Programs The U.S. Drug Enforcement Administration (DEA) sponsors National Prescription Drug Take Back Day in communities nationwide. Many communities also have their own drug take back programs. Check with your local law enforcement officials to find a location near you or with the DEA to find a DEA-authorized collector in your community. You can also check with your pharmacist. Some pharmacies have mail-back programs and disposal kiosks for unused medicines. How to Dispose of Medicines at Home When a take-back option is not readily available, there are two ways to dispose of prescription and over-the counter (OTC) medicine, depending on the drug.