Food and Drug Administration
March 12, 2003
Briefing Information
Accelerated Drug Approvals, FDA Review
Introduction (PDF)
Attachment I - Final Rule (PDF)
Attachment II - Reinventing the Regulation of Cancer Drugs (PDF)
Attachment III A - Letter to SEQUUS Pharm., Inc., FDA (PDF)
Attachment III B - Letter to U.S. ioscience, Inc., FDA (PDF)
Attachment III C - Letter to Seragen, Inc., FDA (PDF)
Attachment III D - Letter to Depo Tech Corp., FDA (PDF)
Attachment III E - Letter to ALZA Corp., FDA (PDF)
Attachment III F - Letter to Schering Corp., FDA (PDF)
Attachment III G - G. D. Searle & Co., FDA (PDF)
Attachment III H - Wyeth-Ayerst, FDA (PDF)
Bibliography (HTM) (PDF) (Word)
Attachment IV - Bibliography (HTM) (PDF) (Word)
Attachment V- Bibliography (HTM) (PDF) (Word)
Background Information Regarding Accelerated Approval of DOXIL® in Kaposi's Sarcoma, Phase IV Commitments, Johnson & Johnson Pharm. (HTM) (PDF) (Word)
Background Information Regarding Accelerated Approval of DOXIL® in Ovarian Cancer, Phase IV Commitments, Johnson & Johnson Pharm. (HTM) (PDF) (Word)
Background Information Regarding ONTAK® (denileukin diftitox), Ligand Pharm. (PDF)
Fulfillment of the Accelerated Approval Requirements for the Non-Small Cell Lung Cancer Indication: Ethyol®, MedImmune Oncology, Inc. (HTM) (PDF) (Word)