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The director of the U.S. Food & Drug Administration’s Center for Drug Evaluation and Research (CDER), George Tidmarsh, was placed on administrative leave on Friday, according to reports. Tidmarsh, a top official overseeing most prescription and over-the-counter drugs, confirmed the move to The New York Times. He told the newspaper he was placed on leave…
The Food and Drug Administration (FDA) is preparing to accelerate the approval process for biosimilar drugs—cheaper versions of complex biologic medicines. Under the plan, companies may need fewer human clinical trials to prove similarity, relying more on analytical testing instead. Biologic drugs account for only about 5% of prescriptions in the U.S., yet they make…
The U.S. Food and Drug Administration (FDA) has selected nine drugs for expedited review under its new National Priority Voucher pilot program, designed to fast-track treatments that address major health needs. Instead of the typical 10–12 month review, these drugs could be approved in one to two months. The FDA says the program will use…
