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FDAs Review Process for New Drug Applications: A Management Review
FDA’s Review Process for New Drug Applications: A Management Review
Our Price: $20.00
Year: 2003
Pages: 47
Binding Paperback

Product Code: 0756746507

Janet Rehnquist (ed). This report by the Office of Inspector General, Dept. of Health & Human Services, assesses how well the Food & Drug Admin. (FDA) manages its new drug application review process. The FDA receives new drug applications (NDAs) from sponsors, typically pharmaceutical companies, & reviews these applications for scientific evidence pertaining to the safety & efficacy of drugs. Based on its assessments, the FDA determines whether drugs can be marketed in the U.S. This inquiry focuses on FDAs Center for Drug Evaluation & Research (CDER), which reviews NDAs. This inquiry does not assess the scientific merit of the decisions that FDA has made. Instead, it examines how well FDA carries out its NDA review process. Illustrations.

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