FDA Guidance for Industry: Field Alert Report Submission - Question and Answers
Titel:
FDA Guidance for Industry: Field Alert Report Submission - Question and Answers
Internet:
Herkunft/Verlag:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM613753.pdf
Inhalt:
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