Home FDA Guidance
FDA Guidance Documents
Print

Guidance documents represent hot moms
the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

General Information Sheet Guidance

 

FDA regulations governing the conduct of clinical trials describe good clinical practices (GCPs) for studies with human subjects:

 

 

Regulations

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Sign up for Good Clinical Practice/Human Subject Protection e-mail updates Get e-mail updates when this information changes.

FDA regulations governing the conduct of clinical trials describe good clinical practices (GCPs) for studies with both human and non-human animal subjects

 

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.

 

Parts 50 and 56

 

Part 54

 

Parts 312 and 314

 

Part 812

 

Part 814

 

Miscellaneous

Last Updated ( Friday, 07 April 2017 09:49 )