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The 200 and 300 series are regulations pertaining to pharmaceuticals : 202-203 Drug advertising and marketing; 210 et seq. cGMPs for pharmaceuticals; 310 et seq. Requirements for new drugs; 328 et seq. Specific requirements for over-the-counter (OTC) drugs. The 500 series are regulations for animal feeds and animal medications: 510 et seq. New ...
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
[code of federal regulations] [title 21, volume 5] [revised as of april 1, 2015] [cite: 21cfr314.50] title 21food and drugs chapter ifood and drug administration department of health and human services subchapter ddrugs for human use part 314 applications for fda approval to market a new drug
It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (USA) and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989. [1]
A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [3] The rule also applies to submissions made to the FDA in electronic format (e.g., a New Drug Application) but not to paper submissions by electronic methods (i.e., faxes). It ...
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
The FDA says they aim to ‘empower’ consumers by redefining healthy foods
Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. [1] RPS is being developed in response to performance goals that the U.S. Food and Drug Administration (FDA) is to achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA). [2]