U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Field Alert Report Submission: Questions and Answers Guidance for Industry
  1. Regulatory Information

GUIDANCE DOCUMENT

Field Alert Report Submission: Questions and Answers Guidance for Industry Guidance for Industry July 2018

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Field Alert Report Submission: Questions and Answers Guidance for Industry

Docket Number:
2018-15389
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Drug Evaluation and Research
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.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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.