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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