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GovernmentDocs 5/5/2008 | 0 (0) | 10 | 0 | 0 | English
Cancer Drugs’ announced how the FDA would apply the accelerated approval rule to new cancer treatments..., CDER, FDA FDA Background Package for November 8, 2005 ODAC Meeting on Accelerated Approvals ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 8 | 0 | 0 | English
industry entitled ‘‘Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.’’ FDA...–0112]Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 71 | 1 | 0 | English
AdministrationMEDWATCHFORM FDA 3500A (10/05)A. PATIENT INFORMATION1. Patient Identifier 2. Age... #General InstructionsSection A - Help3. Sex FemaleFDA Use OnlyC. SUSPECT PRODUCT(S ... more>>
GovernmentDocs 5/5/2008 | 0 (0) | 15 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 15 | 0 | 0 | English
13 years. Materials and Methods: The FDA granted marketing approval to 71 oncology drug applications... Accelerated approval Not approvableconsidered clinical benefit. In 1991, the FDA and National Cancer ... more>>
FDADocs 5/8/2008 | 0 (0) | 18 | 0 | 0 | English
approval from FDA before they may be marketed. The content of PMA applications is governed by both the... Advice-Premarket Approval (PMA), available at http://www.fda.gov/cdrh/devadvice/pma/. See, e.g ... more>>
FDADocs 5/5/2008 | 0 (0) | 12 | 0 | 0 | English
Summary of Basis for Approval: Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method--AdvateSummary of Basis for ApprovalSTN: Drug Licensed Name: 125063/0 Antihemophilic Factor ... more>>
GovernmentDocs 5/4/2008 | 0 (0) | 18 | 0 | 0 | English
*Summary of Basis for Approval96-1048 Coagulation Factor IX (Recombinant)Reference Number... expected to increase {he circulatingSummary Basis for Approval: 96- 1048 Coagulation Factor IX ... more>>
FDADocs 5/9/2008 | 0 (0) | 12 | 0 | 0 | English
SUMMARY FOR BASIS OF APPROVALREFERENCE NUMBER: DRUG LICENSED NAME: MANUFACTURER92-0465HEPATITIS A VACCINE (INACTIVATED) SMlTHKLlNE BEECHAM BlOLOGlCALSHAVRIXTMDRUG TRADE NAME ... more>>
Mythri 1/23/2008 | 0 (0) | 51 | 0 | 0 | English
Sample letter for Sale on Approval Acknowledgment. ... more>>
FDADocs 5/9/2008 | 0 (0) | 15 | 0 | 0 | English
ASH/FDA Workshop on Endpoints in Acute LeukemiaFrederick R. Appelbaum, MD June 24, 2005ASH/FDA Workshop on Endpoints in Acute LeukemiaTimelineAugust 2004 September 2004 October ... more>>
FDADocs 5/9/2008 | 0 (0) | 7 | 0 | 0 | English
implemented before FDA approval upon acknowledgment by FDA that the subnpission is being processed as a... Reaction and Device Defect Reporting” requirements in the “Conditions of Approval” for this PN4A. FDA has ... more>>
FDADocs 5/9/2008 | 0 (0) | 13 | 0 | 0 | English
implemented before FDA approval upon acknowledgment by FDA that the subnpission is being processed as a... Reaction and Device Defect Reporting” requirements in the “Conditions of Approval” for this PN4A. FDA has ... more>>
FDADocs 5/9/2008 | 0 (0) | 13 | 0 | 0 | English
Nomination and Approval of CBER Inspectors and Product Specialists Assigned to Conduct Inspections..., ___________ BranchRequest for FDA CredentialsThe request for [name of CBER employee] to ... more>>
FDADocs 5/9/2008 | 0 (0) | 11 | 0 | 0 | English
representsthe Food and Drug Administration’ (FDA) determination s that an ANDA may be submitted for the above-referenceddrug product. Under Section 505(j)(2)(C)(i) of the Act,.the FDA must approve a petition ... more>>
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