Food and Drug Administration Modernization Act (FDAMA)

 The Food and Drug Administration Modernization Act (FDAMA) was a law passed in 1997 in the United States with the aim of improving the regulation and oversight of the pharmaceutical industry. The act included provisions to speed up the approval process for new drugs and medical devices, increase funding for the FDA, and encourage the development of new treatments for serious or life-threatening conditions.

One of the most significant changes introduced by FDAMA was the creation of the "Fast Track" program for drug development, which allows companies to submit drugs for expedited review if they show promise in treating serious conditions and fill an unmet medical need. The act also established the "Priority Review" program, which shortens the review time for drugs that offer significant improvements over existing treatments.

FDAMA also required the FDA to develop guidance on the use of new technologies in drug development and to establish a system for tracking adverse events related to medical devices. In addition, the act established new rules governing the use of off-label drug information by pharmaceutical companies.

Overall, FDAMA has had a significant impact on the regulation of the pharmaceutical industry in the United States and has played a key role in facilitating the development and approval of new treatments for a range of conditions.

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