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GovernmentDocs 5/4/2008 | 0 (0) | 61 | 3 | 0 | English
DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Rockville, MD 20857September 28, 2006Reference Number: Dear Aripiprazole ANDA Applicant: This letter i... ... more>>
FDADocs 5/9/2008 | 0 (0) | 60 | 0 | 0 | English
DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health ServiceFood and Drug Administration Rockville, MD 20857NDA 18-662/S046Hoffman-La Roche Inc. Attention: Joanna Wau... ... more>>
FDADocs 5/9/2008 | 0 (0) | 60 | 0 | 0 | English
MEMORANDUMDEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCHDATE: FROM:March 3, 2006 Tho... ... more>>
FDADocs 5/9/2008 | 0 (0) | 60 | 0 | 0 | English
Vaccine Safety: An FDA PerspectiveKaren Midthun, M.D. Deputy Director Center for Biologics Evaluation and Research U.S. FDAAmerican Course on Drug Development and Regulatory Sciences Washington ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 58 | 0 | 0 | English
Guidance for Industry and FDA Staff Premarket Approval Application Filing ReviewDocument issued on: May 1, 2003 This document supersedes PMA Filing Decisions (P90-2), dated May 18, 1990 and PMA ... more>>
FDADocs 5/9/2008 | 0 (0) | 58 | 1 | 0 | English
FDA Regulations and Recommendations for Failure InvestigationsHoi-may Wong, BS, MT(ACSP)SBB Blood and Plasma Branch Division of Blood Applications, FDA, CBER, OBRRFDA Workshop Licensure of ... more>>
MissPowerPoint 5/16/2008 | 0 (0) | 56 | 1 | 0 | English
May 16, 2008 04:02 PM Eastern Daylight TimeFDA Grants Approval to Begin Landmark Cardiac... defibrillators, announced today the FDA approval to begin an international, prospective, randomized ... more>>
FDADocs 5/8/2008 | 0 (0) | 55 | 2 | 0 | English
Safety PageHow FDA reviews drug namesEditors??? note: According to a 1999 Institute of Medicine report, approximately 7,000 deaths occur yearly due to medication errors. To help save lives, the ... more>>
FDADocs 5/9/2008 | 0 (0) | 55 | 1 | 0 | English
Evaluation of Biotechnology-Derived Pharmaceuticals (July 1997) (http://www.fda.gov/cder/guidance ... more>>
FDADocs 5/8/2008 | 0 (0) | 54 | 0 | 0 | English
Safety PageTable 1.Med error reports to FDA show a mixed baghe medication errors staff in... Adverse Event Reporting System (AERS) database for all cases of medication errors. Since the FDA often ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 53 | 0 | 0 | English
FDA???s FY 2009 Congressional Justifications Online Performance Appendix January 30, 2008Introduction The Online Performance Appendix is one of several documents that fulfill the Department of ... more>>
FDADocs 5/8/2008 | 0 (0) | 53 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 53 | 0 | 0 | English
Rec???d from Rick Irwin 12/22/05/updated to include comments LR 01.02.06FDA-NTP Studies of Insertional Mutagenesis: Pilot Study Revision Date: 01.02.06 Reason for Revision: To include comments ... more>>
FDADocs 5/9/2008 | 0 (0) | 52 | 0 | 0 | English
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Pharmacoepidemiology and Statistical Science Office of B... ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 52 | 0 | 0 | English
Information Sheet Guidance For IRBs, Clinical Investigators, and SponsorsFDA Institutional Review... 5600 Fishers Lane Rockville, MD 20857 (Tel) (301)-827-3340 http://www.fda.gov/oc/gcp/guidance.htmlU.S ... more>>
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