FDA Modernization

["Marjorie L. Moorefield" <minx32@xxxxxxxxxxx>]

Thanks Murray for the information,
I'm not the only one in the USA who
obviously felt the FDA needed to update.
Click on HTML format if you don't
have  Acrobat Reader
installed on your computer.
BTW, Acrobat Reader is free,
all you have to do is download it.

just me,
Marjorie



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)
·       ·       Press Release about Report
FDAMA Implementation Chart
FDA's FDAMA Accomplishments One Year After Enactment (Nov. 23, 1998)
FDAMA Archives
FDAMA Contacts in the Office of Planning:
·       Butch Bosin, Planning Director: 301-827-5226
·       Michele Bonhomme, Deputy Director: 301-827-5206
·       Steve Chasin, FDAMA: 301-827-5207
·       Cathy Songster, FDAMA: 301-827-5262