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Report to FDA:
Good Clinical Practice (GCP)
is a standard for the design, conduct, performance, monitoring,
auditing, recording, analysis, and reporting of clinical trials.
The Good Clinical Practice Program is the focal point within
FDA for Good Clinical Practice issues arising in human research
trials regulated by FDA.
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Regulations
Current guidance on good clinical practice and
the conduct of clinical trials.
Details about these proposals and instructions
for submitting comments.
Warning letters, disqualification proceedings, restricted list,
adequate assurances list ...
Approvals of drugs, medical devices, biologicals, animal drugs,
food additives.
Links to relevant Compliance Program Guidance
Manuals.
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