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- FDA seeks new advisory committee members, signaling renewed focus on external expertiseThe FDA announced it is inviting subject‑matter experts and consumer representatives to serve on its advisory committees. The call follows a period when the advisory committees had a reduced role…
- Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rulesIndustry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…