- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Global Regulatory Operations and Policy, Office of Regulatory AffairsOffice of Medical Products and Tobacco, Center for Drug Evaluation and ResearchOffice of Medical Products and Tobacco, Center for Biologics Evaluation and Research
This guidance provides the agency’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help increase their consistency and relevancy. The guidance also addresses certain frequently asked 21 questions.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 2018-15389.