Docket Number: FDA-2008-D-0610 Issued by:
Guidance Issuing Office
Office of Foods and Veterinary Medicine, Center for Food Safety and Applied Nutrition
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Devices and Radiological Health
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research
This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products,2 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 events3 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 FDAs 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
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets ManagementFood and Drug Administration5630 Fishers Lane, Rm 1061Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2008-D-0610.
03/19/2020
See the original post here:
Postmarketing Adverse Event Reporting for Medical Products and Dietary - FDA.gov
