FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New.@ CDER

horizonal rule
 
Powered by Google
 

These topics, sorted by title, are supplied by the CDER Freedom of Electronic Information Office. They have been redacted or edited to remove confidential information. Click on the title to view the topic in Adobe Acrobat format. For further information about Adobe Acrobat and download instructions, click here.

Special Interest Topics
Title Document Date Date Posted
Bioresearch Monitoring Information System File 4/10/2008 4/10/2008
1996-1997 Cohort Report (CDER) as of 12/31/1997 [6.9 MB] 12/31/1997 3/18/1998

Committee for Advanced Scientific Education Seminar Series, "The Use of Placebos in Clinical Trials and the Ethics of the Use of Placebos"

4/21/99 6/8/99
Dilantin Injection Recalls, D005-6 and D232-5 [3 MB] 10/11/1995 12/5/1997
Exclusivity Decision on Propofol Injectable Emulsion
Part 1
Part 2
Part 3
3/17/1997 2/18/1999
Good Laboratory Practices Regulations (Management Briefings, 8/79) and GLP Regulations (Questions/Answers, 6/81) [3.6 MB] 8/1979
6/1981
11/17/1997
Good Laboratory Practices - Quarterly Compliance Report [4.2 MB] 12/31/1996 11/5/1997
Health Hazard Evaluation Summary of a Kit for Intrauterine Insertion of Quinacrine Hydrochloride Pellets for Female Sterilization. 8/28/1998 2/2/1999
Inactive Ingredient Guide (Redacted) January 1996 1/1996 3/15/2000
IND 38,108 Phase IV Protocol [3.8 MB] 6/27/1997 3/20/1998
Medical Officer Review of NDA 20-344, Amendment 019, Part 1A (IPPH Study) [852 KB] 9/8/1995 2/10/1998
Memo from Dr. Burlington Regarding Advisory Committee [949 KB] 9/30/1991 12/5/1997
Memo from Dr. Temple Regarding Advisory Committee [2 MB] 7/8/1992 12/5/1997
Office of Generic Drugs LVP Correspondence [6 MB] 8/26/1997 2/10/1998
Phase IV Protocol of Glucophage (NDA 20-357)
Part 1 [2 MB]
Part 2 [2 MB]
10/1997 6/16/1998
Propofol Injection Exclusivity Decision [4 MB] 3/17/1997 3/23/1998
Quantitative Report (Office of Generic Drugs, 9/96 - 7/97) [1.6 MB] 10/1/1997 11/17/1997
Synthroid Meeting Minutes [280 KB] 1/8/1997 11/17/1997
Treatment IND List Allowed to Proceed [23 KB] 6/22/1987-2/19/2002 8/8/2002

 

Back to CDER FOI Page

Last updated: March , 2008

horizonal rule