FDA Guidance for Industry: Field Alert Report Submission Questions and Answers

Title:
FDA Guidance for Industry: Field Alert Report Submission Questions and Answers

https://www.gmp-compliance.org/files/guidemgr/24740676_FAR (1).pdf

Origin/Publisher:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM613753.pdf

Content:
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

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