Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)

Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services. issuing body.
United States. Food and Drug Administration. issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Language(s):
English
Format:
Text
Subject(s):
Biological Availability
Therapeutic Equivalency
Biopharmaceutics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Genre(s):
Technical Report
Abstract:
This guidance describes FDA's compliance policy related to the retention of reserve samples of the test article and reference standard used in an in vivo bioavailability (BA) and in vivo or in vitro bioequivalence (BE) study. Specifically, this guidance: (1) Addresses the requirement at 21 CFR 320.38(c) to retain reserve samples of sufficient quantity to permit FDA to perform five times all the release tests required in an application or supplemental application; (2) Describes the conditions under which the Agency does not generally intend to take enforcement action against an applicant or contract research organization (CRO) for retaining less than the quantity of reserve samples of the test article and reference standard that were used in the BA or BE study as specified in 21 CFR 320.38(c).
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (6 pages)).
NLM Unique ID:
9918227359206676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227359206676