Removal of regulations regarding certification of drugs composed wholly or partly of insulin; companion document to direct final rule--FDA. Proposed rule.
The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to repeal FDA's regulations governing certification of drugs containing insulin and make conforming amendments to other sections of the agency's regulations. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified drugs containing insulin. FDAMA also made conforming amendments to the act.
D002568:Certification / Q000331:legislation & jurisprudence / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007004:Hypoglycemic Agents; D007328:Insulin; D014481:United States; D014486:United States Food and Drug Administration