FDA Rejects Limits On Psychiatric Drugs

Drug makers seeking U.S. approval of new drugs to treat major depression should not be required to first provide data on how well they work long-term, a Food and Drug Administration advisory panel recommended on Tuesday. The FDA is considering calling for upfront data on how well psychiatric drugs work over time before it approves them. The agency usually follows the advice of its advisory panels. Panelists agreed long-term data could help doctors treat patients, but voted unanimously against new requirements, siding with patient and industry representatives concerned about slowing the delivery of new medicines.

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