Food and Drug Administration Modernization Act Law and Legal Definition
The Food and Drug Administration Modernization Act of 1997 aims at reducing the time for the approval of new pharmaceutical drugs. The Act aims at reforming the regulations on food, medical products, and cosmetics. The Act modifies the process of getting approval for clinical studies and improves pharmaceutical research and drug delivery.
The provisions of the Act include:
1. prescribing drug user fees;
2. FDA initiatives and programs;
3. information’s on off label and drug economics;
4. pharmacy compounding;
5. risk based regulation of medical devices;
6. food safety and labeling; and
7. medical product standards.
The Act amends the Federal Food, Drug, and Cosmetic Act.
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