Accelerating access to cancer drugs

Journal of Biolaw and Business

Volumn 2, Issue 2, 1999, Pages 38-44

  Shulman, Sheila R ^a   Wood Armany, Maria J ^b  

^a UNIVERSITY AT BUFFALO   (United States)

^b Tufts Ctr the Stud of Drug Devmt   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; BICALUTAMIDE; CLADRIBINE; DOCETAXEL; FLUDARABINE PHOSPHATE; GEMCITABINE; IFOSFAMIDE; IRINOTECAN; LEVAMISOLE; MESNA; NAVELBINE; PACLITAXEL; PENTOSTATIN; RAZOXANE; TENIPOSIDE;

CANCER THERAPY; DRUG DISTRIBUTION; DRUG MANUFACTURE; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; POLICY; REVIEW;

EID: 0032957185     PISSN: 10955127     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (50)

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2. In 1976, the FDA and the National Cancer Institute introduced the Group C program, which authorized the distribution of investigational anticancer agents for treatment purposes. Subsequent FDA initiatives targeted drugs intended for a broader range of conditions considered to be serious or life-threatening.
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6. Pub. L. No. 105-115, 111 Stat. 2296 (Nov. 21, 1997).
7. Prescription Drug User Fee Act of 1992, Pub. L. No. 102-571 (Oct. 29, 1992), 21 U.S.C. 379, 106 Stat. 4491; S.R. Shulman & K.I. Kaitin, The Prescription Drug User Fee Act of 1992: A Five Year Experiment for Industry and the FDA, 2 PHARMACOECONOMICS 121-33 (Feb. 1996).
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10. FDA review is not necessarily synonymous with FDA approval. The FDA review period ends with the issuance of an action letter, which may take one of three forms: an approval letter, an approvable letter (specifying an application's deficiencies and the steps needed to rectify the problems), or a non-approvable letter.
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21. The database includes NCEs approved in the US from 1963 to the present. An NCE is defined as any new molecular compound not previously approved in the US, excluding vaccines, diagnostic agents, new salts, esters, and dosage forms of previously approved compounds. A small number of biologics reviewed and approved by the FDA's CDER are included in the database and in the samples discussed in this commentary.
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