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Title IX prohibits a "responsible person" from introducing into interstate commerce a new drug, if the person is in violation of a requirement related to post-approval clinical trials or labeling changes. It authorizes the FDA to require a responsible person for a drug to conduct a post-approval study or clinical trial of the drug to assess a ...
An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
The documentation required in an NDA is supposed to tell "the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.” [2] Once approval of an NDA is obtained, the new ...
Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: 11 — electronic records and electronic signature related; 50 Protection of human subjects in clinical trials; 54 Financial disclosure by clinical investigators [2] 56 Institutional review boards that oversee clinical trials
The FDA requires a four-phased series of clinical trials for testing drugs. Phase I involves testing new drugs on healthy volunteers in small groups to determine the maximum safe dosage. Phase II trials involve patients with the condition the drug is intended to treat to test for safety and minimal efficacy in a somewhat larger group of people.
Statutory standards for BLA approval are largely the same as those for New Drug Application approval. According to 21 CFR 600.3, FDA interprets "potency" to include effectiveness of the biologic. After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.
FDA's guidance, which is not legally binding, is typically followed by companies seeking the agency's approval for their products. The FDA will require companies to file plans on how they intend ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.