Parts 50 and 56
Protection of Human Subjects; Informed Consent (January 27, 1981)
Protection of Human Research Subjects; Standards for Institutional Review Boards for Clinical Investigations (January 27, 1981)
Protection of Human Research Subjects; Clinical Investigations Which May Be Reviewed Through Expedited Review Procedure Set Forth in FDA Regulations (January 27, 1981)
Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations (November 1988)
Federal Policy for the Protection of Human Subjects (June 18, 1991)
FDA Policy for the Protection of Human Subjects (June 18, 1991)
Protection of Human Subjects; Informed Consent; Proposed Rule (September 21, 1995)
Protection of Human Subjects; Informed Consent, Part II (October 2, 1996) [html]
Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules (October 2, 1996) [text]
Protection of Human Subjects; Informed Consent (December 22, 1995)
Protection of Human Subjects; Informed Consent Verification; Final Rule (November 5, 1996)
Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure (November 9, 1998)
Additional protections for children (66 FR 20589-600, April 24, 2001)
Part 54
Financial Disclosure by Clinical Investigators; Final Rule (December 31, 1998)
Financial disclosures by a Clinical Investigator (63 FR 72171-81, December 31, 1998)
Parts 312 and 314
Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations (June 9, 1983)
New Drug and Antibiotic Regulations (February 22, 1985)
New Drug, Antibiotic, and Biologic Drug Product Regulations (March 19, 1987)
Investigational New Drug Applications and New Drug Applications (September 8, 1995)
Investigational New Drug Applications and New Drug Applications (February 11, 1998)
Disqualification of a Clinical Investigator (February 16, 1996)
Disqualification of a Clinical Investigator (September 5, 1997)
Expedited Safety Reporting Requirements for Human Drug and Biological Products (October 7, 1997)
Clinical Hold for products intended for life threatening conditions (65 FR 34963-71, June 1, 2000)
Part 320
Retention of BE and BA testing samples (April 28, 1993)
Part 812
Quality System Regulations (October 7, 1996)
Treatment Use of Investigational Devices (September 18, 1997)
Withdrawal of Intraocular Lenses Regulation (Part 813) (January 29, 1997)
Disqualification of Clinical Investigators (March 14, 1997)
Modifications to the List of Recognized Standards (July 12, 1999)
Modifications to the Medical Device and/or Study Protocol (November 23, 1998)
Part 814
Medical Devices; Humanitarian Use Devices Part V (June 26, 1996)
30-Day Notices and 135-Day PMA Supplement Review (October 8, 1998)
Humanitarian Use of Devices (November 3, 1998)
Miscellaneous
Use of BMIS (63 FR 55873-6, October 19, 1998)
Presiding officer (66 FR 45317-8, August 28, 2001)