Search results
Results From The WOW.Com Content Network
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved, as outlined in 21 CFR 312.42. An IND must be labeled "Caution: New Drug – Limited by Federal (or United States) law to investigational use," per 21 CFR 312.6
Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application ; Code of Federal Regulations, Title 21, Part 201.56 (and Part 201.57) CDER Guidance for Industry. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. CDER Guidance for Industry.
21 U.S.C. ch. 22 — National Drug Control Policy Office of National Drug Control Policy; 21 U.S.C. ch. 23 — [National Youth Anti-Drug Media Campaign] (repealed) 21 U.S.C. ch. 24 — International Narcotics Trafficking; 21 U.S.C. ch. 25 — Miscellaneous Anti-Drug Abuse Provisions
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
[citation needed] FDA authority is exercised through enforcement of regulations derived from legislation, as published in the U.S. Code of Federal Regulations (CFR); the principal drug safety regulations are found in 21 CFR Part 312 (IND regulations) and 21 CFR Part 314 (NDA regulations).
A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration. The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.