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Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic
Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
United States. Food and Drug Administration. Office of Counterterrorism and Emerging Threats, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Center for Food Safety and Applied Nutrition (U.S.), issuing body. - Publication:
- Silver Spring, MD : Office of Counterterrorism and Emerging Threats, May 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Dietary Supplements -- adverse effects
Drug-Related Side Effects and Adverse Reactions
Equipment Design -- adverse effects
Equipment Safety
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic. FDA believes this approach will make it possible for firms with reporting responsibilities to focus their limited resources on the following types of reports: reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic; other reports indicated in this guidance; reports on products presenting special concerns as specified by FDA. FDA is revising the final guidance for industry entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic" (2012 final guidance) to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic. This action is necessary to address the Coronavirus Disease 2019 (COVID-19) pandemic and to ensure that the Agency’s recommendations in the 2012 final guidance apply to any pandemic, including COVID-19. Accordingly, this guidance replaces the 2012 final guidance.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (11 pages)).
- NLM Unique ID:
- 9918231200306676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918231200306676