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