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  1. Clinical Trials and Human Subject Protection

Regulations: Good Clinical Practice and Clinical Trials

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Here are links to FDA regulations governing human subject protection and the conduct of clinical trials.

Preambles to GCP Regulations

Each time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA develops rules to implement the law. The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA's interest in formulating, amending or repealing a rule, and offering the public the opportunity to comment on the agency's proposal. The Federal Register notice explains the legal issues and basis for the proposal, and provides information about how interested persons can submit written data, views, or arguments on the proposal. Any comments that are submitted are addressed in subsequent publications that are part of the agency's decision-making process.

The "preamble" to each of these publications includes all of the printed information immediately preceding the codified regulation. The preamble provides information about the regulation such as why the regulation is being proposed, the FDA's interpretation of the meaning and impact of the proposed regulation, and in those cases where the agency has solicited public comment, the agency's review and commentary on those comments . The preamble can also include an environmental impact assessment, an analysis of the cost impact, comments related to the Paperwork Reduction Act, and the effective date of the implementation or revocation (as the case may be) of the regulation.

The documents posted below include the various publications that contributed to the development of final rules related to FDA's regulations on good clinical practice and clinical trials.

Part 50- Informed Consent

Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products; 21 CFR 50, Subpart D

Part 56- Institutional Review Boards

IRB Registration Requirements 21 CFR 56.106

IRB Shopping: Requiring Sponsors and Investigators to Inform Institutional Review Boards of Any Prior Institutional Review Boards Reviews

IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

Part 54- Financial Disclosure by Clinical Investigators

Part 210- Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

Part 312- Investigational New Drug Application

Part 314 – Applications for FDA Approval to Market a New Drug
Part 601 – Applications for FDA Approval of a Biologic License

Part 320- Bioavailability and Bioequivalence Requirements

Part 812- Investigational Device Exemptions

Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

Part 814- Premarket Approval of Medical Devices



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