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FDADocs 5/8/2008 | 0 (0) | 7 | 0 | 0 | English
Cancer Nanotechnology: New Opportunities for Targeted TherapiesFDA Public Meeting October 10, 2006Piotr Grodzinski, Ph.D. Director, Nanotechnology for Cancer Programs Office of Technology and ... more>>
FDADocs 5/9/2008 | 0 (0) | 46 | 1 | 0 | English
Evaluation of Biotechnology-Derived Pharmaceuticals (July 1997) (http://www.fda.gov/cder/guidance ... more>>
FDADocs 5/5/2008 | 0 (0) | 30 | 0 | 0 | English
FDA/NIH Joint Symposium on Diabetes Targeting Safe and Effective Prevention and Treatment May... Evaluation and Research (CDER), Food and Drug Administration (FDA), U.S. Department of Health and Human ... more>>
FDADocs 5/9/2008 | 0 (0) | 16 | 0 | 0 | English
1. HOME DISTRICT2. REPORTING UNIT SYMBOL3. CENTRAL FILE NO.4. J.D./T.A.5. COUNTY6. DATENWE7. PRODUCT CODENOL8. OPERATION1234567 09001----... ... more>>
FDADocs 5/9/2008 | 0 (0) | 12 | 0 | 0 | English
ERRATA FDA ODAC BRIEFING DOCUMENT SEPTEMBER 13, 2005 MEETING NDA 21473/S-003 TARCEVA PANCREATIC ADENOCARCINOMA General: There may be some confusion in the document regarding which analysis is the ... more>>
FDADocs 5/9/2008 | 0 (0) | 15 | 0 | 0 | English
SAMPLE NO.AFFIDAVIT(Parcel Post/Parcel Service)STATE OF COUNTY OF2358 PuebloColoradoBefore me,Sidney H. Rogers an employee of the Department of Health and Human... ... more>>
FDADocs 5/9/2008 | 0 (0) | 33 | 0 | 0 | English
THE CENTER FOR LIFESTYLE DISEASE~b-6 ~7~P.O . Box 1487" Surprise, AZ 85378July 18, 2006FDA Pre Market Notification for "Absolbotani"Submitted By: This Pre Market Notification is being ... more>>
FDADocs 5/9/2008 | 0 (0) | 32 | 0 | 0 | English
Session II:Exjade?? Phase 4 requirementsExjade ?? (deferasirox) Tablets for Oral Suspension (accelerated approval Nov. 2, 2005)DEPARTMENT OF HEALTH & HUMAN SERVICESPub... ... more>>
FDADocs 5/9/2008 | 0 (0) | 28 | 0 | 0 | English
Session II:Exjade?? Phase 4 requirementsExjade ?? (deferasirox) Tablets for Oral Suspension (accelerated approval Nov. 2, 2005)DEPARTMENT OF HEALTH & HUMAN SERVICESPub... ... more>>
FDADocs 5/8/2008 | 0 (0) | 22 | 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) | 18 | 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) | 11 | 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) | 17 | 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) | 20 | 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) | 64 | 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>>
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