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- FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy TudriqevA senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…
- FDA vows tighter review of foreign clinical trial data amid rising Chinese influenceTop FDA officials announced that the agency will intensify its oversight of clinical trial data generated outside the United States. The move is aimed at ensuring that foreign data meet the same st…