The Food and Drug Administration Modernization Act, enacted Nov. 21, 1997, amended the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products. With the passage of FDAMA, Congress enhanced FDA's mission in ways that recognized the Agency would be operating in a 21st century characterized by increasing technological, trade and public health complexities.
- Full text of the Act in HTML
- Full text of the Act in PDF (399K)
- Backgrounder summarizing the most important provisions of the Act.
Communicating with
Our Stakeholders:
In Section 406(b) of FDAMA, Congress recognizes that FDA's responsibilities
are vast and that the Agency's stakeholders can play an important role
in helping the Agency determine how best to meet these responsibilities.
Answers to Stakeholders' Questions
FDA Plan for Statutory
Compliance (November 1998)
The plan is also available in PDF
format (504K).
- Corrections to the Plan
(Federal Register Notice Dec. 17, 1998)
This document is also available in PDF format (20K). - Mechanisms for Meeting Review Time Periods (July 2, 1999)
- Report on FDA Plan for Statutory Compliance (September 2000)
FDA's FDAMA Accomplishments One Year After Enactment (Nov. 23, 1998)
FDAMA Contacts in the Office of Planning:
- Steve Chasin, FDAMA: 301-827-5207
- Cathy Songster, FDAMA: 301-827-5262
Some of these documents are in Portable Document
Format (PDF) to retain the original format. To view or
print these documents, you must use the Adobe Acrobat viewer. Acrobat
is free and available directly from Adobe's website with full installation
instructions.
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Web page updated by clb
2002-AUG-21.