Food and Drug Administration

Oncologic Drugs Advisory Committee

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)