Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience

Author:

Milne Christopher-Paul,Bergman Elaine

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug guides,Pharmacology (nursing)

Reference15 articles.

1. Food and Drug Administration. Guidance for Industry: Fast Track Drug Development Programs—designation, development, and application review. Rockville, MD: Food & Drug Administration; September 1998.

2. Another view on industry response to fast track program. US Regulatory Reporter. 1998 Sep;15(3):1–2.

3. Drug industry has not yet embraced FDAMA’s “Fast Track” program. US Regulatory Reporter. 1998 Aug; 15(2):1–3.

4. An interview with Director of the Division of Cardio-renal Drug Products Raymond Lipicky, M.D. US Regulatory Reporter. 1999 Oct;16(4):3–7.

5. PhRMA proposals for fast-track products. Pharma Marketletter. 1998 Apr 27;25(7):13.

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