Drugs
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CDER FOIA Electronic Reading Room
Handbook for Requesting Information and Records from FDA
Final Opinions
Policy Statements
Administrative Staff Manuals
Frequently Requested Records
- FDA Warning Letters
- Division of Drug Marketing, Advertising and Communications Correspondence
- Advisory Committees
- Disqualified/Restricted/Assurance List for Clinical Investigators
- Drug Approval Packages, Approval Letters, Summary Reviews (Drugs@FDA)
- Investigational Human Drugs: Clinical Investigator Inspection List
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CDER Special Interest Topics
1996-1997 Cohort Report (CDER) as of 12/31/1997 (PDF - 6.8MB)Committee for Advanced Scientific Education Seminar Series, The Use of Placebos in Clinical Trials and the Ethics of the Use of Placebos (TXT - 136KB)Dilantin Injection Recalls, D005-6 and D232-5 (PDF - 3.2MB)Exclusivity Decision on Propofol Injectable Emulsion Good Laboratory Practices Regulations (Management Briefings, 8/79) and GLP Regulations (Questions/Answers, 6/81) (PDF - 3.6MB)Good Laboratory Practices - Quarterly Compliance Report (PDF - 4.2MB)Health Hazard Evaluation Summary of a Kit for Intrauterine Insertion of Quinacrine Hydrochloride Pellets for Female Sterilization (PDF - 957KB)IND 38,108 Phase IV Protocol (PDF - 3.7MB)Medical Officer Review of NDA 20-344, Amendment 019, Part 1A (IPPH Study) (PDF - 852KB)Memo from Dr. Burlington Regarding Advisory Committee (PDF - 949KB)Memo from Dr. Temple Regarding Advisory Committee (PDF - 1.9MB)Office of Generic Drugs LVP Correspondence (PDF - 6MB)Phase IV Protocol of Glucophage (NDA 20-357) Propofol Injection Exclusivity Decision (PDF - 4.2MB)Quantitative Report (Office of Generic Drugs, 9/96 - 7/97) (PDF - 1.6MB)Synthroid Meeting Minutes (PDF - 180KB)Treatment IND List Allowed to Proceed (PDF - 73KB)
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