FDA Regulations Relating to Good Clinical Practice and Clinical Trials

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Rina
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FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Electronic Records; Electronic Signatures (21 CFR Part 11)
Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
Financial Disclosure by Clinical Investigators (21 CFR Part 54)
Institutional Review Boards (21 CFR Part 56)
Investigational New Drug Application (21 CFR Part 312)
Foreign Clinical Trials not conducted under an IND (21 CFR Part 312.120)
Forms 1571 (Investigational New Drug Application) and 1572 (Statement of Investigator)
Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
Bioavailability and Bioequivalence Requirements (21 CFR Part 320)
Applications for FDA Approval of a Biologic License (21 CFR Part 601)
Investigational Device Exemptions (21 CFR Part 812)
Premarket Approval of Medical Devices (21 CFR Part 814

For details see (http://www.fda.gov/oc/gcp/regulations.html)