Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations
- Collection:
- Health Policy and Services Research
- 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, June 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Administration, Oral Drug Approval Drugs, Investigational Food-Drug Interactions Government Regulation United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products under investigational new drug applications (INDs) to support new drug applications (NDAs) and supplements to these applications for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). This guidance revises and replaces part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002). Information on fed bioequivalence (BE) studies to be submitted in abbreviated new drug applications (ANDAs) is now found in the FDA guidance entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (August 2021). Specific recommendations concerning fed comparability studies are now described in the FDA guidance entitled Bioavailability Studies Submitted in NDAs or INDs — General Considerations (April 2022). The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 15 pages))
- NLM Unique ID:
- 9918486680006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918486680006676