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Welcome to FDAMA

Last Update: 01-31-2005

Welcome to ORA's Modernization Act web page. This page has been created to provide you with timely access to various documents published as part of FDA's Modernization Act implementation efforts. The Agency is continuing to develop the regulations and guidance documents and complete other related tasks required by the new law. Additional documents of interest to ORA will be added as they are completed.

FDA Information on FDAMA- This link will take you to the Agency's Modernization Act page, the central access point for all activities related to the implementation of FDAMA.

FDAMA Section 406(b): Communicating with Our Stakeholders

Specific FDAMA Issues and Topics of Interest

Foreign Establishment Registration and Listing Manufacturing Changes to Approved Applications
Antibiotics and Insulin Information Dissemination on Unapproved Uses
Pharmacy Compounding Mutual Recognition Agreements
Positron Emission Tomography (PET) Radiopharmaceuticals