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FDADocs 5/8/2008 | 0 (0) | 24 | 0 | 0 | English
Nanotechnology-Enabled Specifically Targeted ViricidesEugene Seymour, MD, MPH Chief Executive Officer Cell: 310-966-1941 eugene@nanoviricides.com Anil R. Diwan, PhD President Cel... ... more>>
FDADocs 5/9/2008 | 0 (0) | 27 | 0 | 0 | English
FDA Briefing PackageCardiovascular and Renal Drugs Advisory CommitteeNovember 16, 2005Application: NDA 21-628 Certican?? (everolimus) Tablets Indication: Prophylaxis of organ rejection in ... more>>
FDADocs 5/9/2008 | 0 (0) | 14 | 0 | 0 | English
Biological Characterization and Impurities Breakout Session BFDA/DIA Scientific Workshop on Follow-on Protein PharmaceuticalsBiological Characterization Robin Thorpe, Ph.D.??? Bioassay ... more>>
FDADocs 5/9/2008 | 0 (0) | 22 | 0 | 0 | English
The Society for the Advancement of Blood Management (www.SABM.org) is a non-profit organization with several mandates dedicated to improving blood management based on evidence-base... ... more>>
FDADocs 5/9/2008 | 0 (0) | 25 | 0 | 0 | English
NDA 21-500 Martine Kraus, Ph.D. Director, Regulatory Affairs Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 Dear Dr. Kraus: Please refer to your new drug applicatio... ... more>>
FDADocs 5/9/2008 | 0 (0) | 85 | 0 | 0 | English
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCHFDA CLINICAL BRIEFING DOCUMENT FOR THE ONCOLOGIC DRUG ADVISORY ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 50 | 0 | 0 | English
IsDEPARTMENT OF HEALTH & HUMAN SERVICESFED 7 2007Sidney Wolfe , M .D . Elizabeth Barbehenn, Ph.D. Public Citizen Health Research Group 1600 20'" Street, NW Washington, ... ... more>>
FDADocs 5/8/2008 | 0 (0) | 18 | 0 | 0 | English
Perspectives on Supplying Attenuation Grades of Titanium Dioxide and Zinc Oxide for Sunscreen ApplicationsDavid Schlossman, Yun Shao, Ph.D., Pascal Delrieu, Ph.D., Kobo Products ... ... more>>
FDADocs 5/9/2008 | 0 (0) | 27 | 0 | 0 | English
NDA 20-720/S-012 NDA 20-720/S-014 Parke-Davis Pharmaceutical Research Attention: Ms. Mary E. Taylor, M.P.H. Director, Worldwide Regulatory Affairs 2800 Plymouth Road Ann Arbor, MI ... ... more>>
FDADocs 5/9/2008 | 0 (0) | 26 | 0 | 0 | English
Review and Evaluation of Clinical Data NDA #21-336Sponsor: Drug: Proposed Indication: Material Submitted: Correspondence Date: Date Received: Related NDA:Somerset Pharmaceu... ... more>>
FDADocs 5/9/2008 | 0 (0) | 26 | 0 | 0 | English
MEMORANDUMDEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCHDATE: FROM:October 12, 2005 ... ... more>>
FDADocs 5/9/2008 | 0 (0) | 37 | 1 | 0 | English
DIVISION OF DRUG ONCOLOGY PRODUCTS Briefing Document for Oncology Drug Advisory Committee NDA: Applicant: Established Drug Name: 21-986, N-000 Bristol-Myers Squibb Dasatinib (BMS-3... ... more>>
FDADocs 5/9/2008 | 0 (0) | 23 | 1 | 0 | English
DIVISION OF DRUG ONCOLOGY PRODUCTS Briefing Document for Oncology Drug Advisory Committee NDA: Applicant: Established Drug Name: 21-986, N-000 Bristol-Myers Squibb Dasatinib (BMS-3... ... more>>
FDADocs 5/9/2008 | 0 (0) | 38 | 2 | 0 | English
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation Research Office of Pharmacoepidemiology and Statistical Science Office of Biost... ... more>>
FDADocs 5/9/2008 | 0 (0) | 28 | 0 | 0 | English
Statistical Review/NDA21-743/SE1-003 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Pharmacoepidemiolog... ... more>>
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