FDA Modernization Act of 1997 – Future Regulatory Improvements

The Food and Drug Administration (FDA) Modernization Act of 1997 was enacted to amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as the provisions of biological products in the public health service Act section 351. This act impact all products controlled by FDA. The FDA Modernization Act of 1997 was drafted to replace the Prescription Drug User Fee Act of 1992 which was supposed to be functional for five years and whose lifespan was ending in the 1997 on the end of September. The legislation was drafted to regulate the manufacturing and selling of pharmaceutical and food products in the American Market (Covington & Burling, 1997).

FDAMA 113 provides that the registry should include information regarding private or federally funded clinical trials carried out under new drug applications investigational to test the experimental drugs effectiveness for patients with life-threatening or serious conditions or diseases. This regulation ensures total protection and safety of all individuals being used in any clinical trial. It also protects children and any other special group from being used for experiment or research purposes, especially in situations where the risks involved are not well known or they are severe (Covington & Burling, 1997).

The current FDA legislative has played a great role in enhancing the drug and food production, marketing and distribution to the country. However, the clinical trials regulation in the section 113 has highly impacted pediatric clinical researches since they hardly get enough participants to use in their clinical trials. This may need to be changed to ensure that some serious conditions are handled effectively as they should among young children (Sharav, 2003).

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