1. Spectrometric Assessment of Generic and Brand Drug Quality for a Sentinel Screening Network.
- Author
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Isaacs JT, Almeter PJ, Henderson BS, Hunter AN, Platt TL, and Lodder RA
- Subjects
- United States, Pharmaceutical Preparations, United States Food and Drug Administration, Drugs, Generic
- Abstract
The U.S. Food and Drug Administration (FDA) is a worldwide leader among analogous regulatory organizations in other countries. The FDA uses current good manufacturing practices to regulate the processes that produce drugs. Nevertheless, investigative journalists have pointed out problems in the drug supply, and pharmacies are not required to test the drugs they receive. The University of Kentucky Drug Quality Study does perform screening on the sterile injectable drugs that it receives and regularly reports new findings to FDA, practitioners, and the public. A Sentinel Screening Network of academic health systems could provide independent data on drug quality to FDA not available through manufacturers.
- Published
- 2023
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