The initiatives coincide with an increase in the volume of data submitted to CDER and CBER—particularly in cell and gene therapy.
Tag Archive for: Center for Drug Evaluation and Research
The FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee voted nearly unanimously to withdraw the approval of Covis’ preterm birth drug Makenna.
The report summarizes various measures of the pharmaceutical industry’s ability to deliver quality drugs to U.S. patients and consumers.