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Documents Released Under the Freedom of Information Act
or Otherwise Publicly Available

Alphabet Soup (US Federal Agencies):
CDER: Center For Drug Evaluation and Research; CBER: Center For Biologics Evaluation and Research; CDRH: Center For Devices and Radiological Health; FDA: Food and Drug Administration (part of HHS); HHS: Health and Human Services; OHRP: Office For Human Research Protections (part of HHS); ORI: Office of Research Integrity (part of HHS); OIG: Office of the Inspector General

US Food & Drug Administration [FDA]

What follows are FDA warning letters organized (as indicated) and alphabetized for sanity; FDA sources are indicated at the bottom of each web page. These letters are redacted as per FDA FOIA policies unless otherwise noted. We update our indices weekly. Annual indices of CDER warning letters to pharmaceutical manufacturers, CBER warning letters, Cyber Letters (dietary supplements-not), NIDPOE (Notice of Initiation of Disqualification Proceedings and Opportunity to Explain), NOOH (Notice of Opportunity for Hearing) lists, current warning letters, debarment and restricted lists, etc., are available on our FDA Information Index

• FDA Warning Letters Issued to Institutional Review Boards
• FDA Warning Letters Issued to Clinical Investigators [A – L]
• FDA Warning Letters Issued to Clinical Investigators [M – Z]
• FDA Warning Letters Issued to Sponsors and Contract Research Organizations
• FDA Form 483s, Notices of Inspection

Documents From Notorious Cases

• Great Lakes College of Clinical Medicine Index of Documents – Research Conducted and Approved the the IRB
• Malariotherapy for HIV (Henry Heimlich M.D. and the Heimlich Institute Foundation Inc.)
• Malariotherapy for Lyme Disease (Henry Heimlich M.D. and the Heimlich Institute Foundation Inc.)
• Miscellaneous Document Holding Page

Coming soon

Litigation and Other Regulatory Actions

• Physician-Researchers (state medical board actions, depositions, and more)
• Institutions and Organizations
• Institutional Review Boards
• Sponsors of Drug and Device Studies

Documents By Topic

• Informed Consents
• Protocols

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Last Updated: 2005-03-30

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