FDA Modernization Act of 1997
Postmarketing Studies [FDAMA 130]
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- Postmarketing Study Commitments
- Report to Congress: Reports on Postmarketing Studies [FDAMA 130] - (PDF - 47 KB)
- FDA Talk Paper: Federal Register Report and FDA Web Site on Postmarketing Studies
- FEDERAL REGISTER: Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status Reports; Final Rule -
10/30/2000 - (PDF - 167 KB) - Guidance for Industry: Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 - 2/15/2006
- FEDERAL REGISTER: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability - 5/21/2003 - (PDF - 75 KB)
CBER Fast Track Designation Request Performance
FDA Modernization Act of 1997 - (PDF - 398 KB)
- FDAMA Implementation Chart
- FDA's FDAMA Accomplishments One Year After Enactment - Talk Paper 11/23/98
FDAMA Section 406(b): Communicating with Our Stakeholders -
- FDA Plan for Statutory Compliance - (PDF - 584 KB)
Correction to plan - Federal Register Notice 12/17/98 - (PDF - 11 KB) - Agency Stakeholder Information
- Calendar / Transcripts of Public Meetings
- CBER Dear Colleague Letter - 3/23/99
- View submitted 406(b) comments
CBER FDAMA Guidances / Rules / Notices
FDA Public / Private Partnership Program - Partnering with the private sector