
FDA clinical trials requirements
FDA Regulations Relating to Good Clinical Practice and Clinical Trials
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.
You might also like


BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.
![]() |
3 Month Supply Yacon Root Extract Syrup Weight Loss Supplement All Natural (180 Capsules) Health and Beauty (Dynamic Systems Nutra)
|
![]() |
Enhanced Saw Palmetto Prostate Support Supplement by Nutrizap : Specially Formulated with Pygeum Bark and Pumpkin Seed Oil : Promotes Prostate and Urinary Health : 120 Capsules : Made in USA Health and Beauty (Nutrizap)
|
![]() |
GHI Yacon Root Extract Pills 1000mg * 100% Organic Pure Yacon Root * Weight Loss * Natural Low-gylcemic Superfood with FOS Prebiotics and Antioxidants * Boost Metabolism * Healthy Digestion & Regularity * High Fiber * Gluten Free, Yacon Syrup Extract 60 Veggie Capsules , Natural and Safe Prebiotic and Probiotic Natural Weight Loss Health and Beauty (GHI Global Health Ideas)
|