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

Volume: 35, Issue: 1, Pages: 71 - 83
Published: Jan 1, 2001
Abstract
With the passage of the Food and Drug Administration Modernization Act (FDAMA), existing programs for expedited development and approval for treatments of serious or life-threatening diseases were codified and consolidated under the administrative rubric of fast track product designation. The four basic programs available with fast track designation have been categorized by FDA as consisting of meetings, written correspondence, review programs,...
Paper Details
Title
Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience
Published Date
Jan 1, 2001
Volume
35
Issue
1
Pages
71 - 83
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