Reporting amount of listed drugs and biological products technical conformance guide
- 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. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Veterinary Medicine (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products Drug Industry Drug Labeling United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- FDA is issuing this Technical Conformance Guide (guide) to assist registrants of drug establishments (or their authorized agents) in submitting reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3112(e) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).3 This guide supplements the draft guidance for industry Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (October 2021). The guide describes 1) how first-time users can access FDA’s CDER NextGen Portal5 (the portal) to submit these reports, 2) the different methods for submitting the reports through the portal, and 3) the data elements to be included in the reports. The data elements described in this guide apply to reports for listed drugs including medical gases;6 homeopathic products; products marketed in accordance with requirements under section 505G of the FD&C Act, often referred to as over-the-counter monograph drugs; and animal drug products that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (17 pages)).
- NLM Unique ID:
- 9918351277006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351277006676