Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format

Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format

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):
Legislation, Drug
Legislation, Food
Marketing -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.
Genre(s):
Technical Report
Abstract:
This guidance is intended to assist holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) approved under section 505(c) and 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(c) and (j)), respectively, with submission of marketing status notifications required under section 506I of the FD&C Act (21 U.S.C. 356i). This guidance identifies the required content for these marketing status notifications and the format by which these notifications should be submitted to the Agency.
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:
9918227267606676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918227267606676