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- FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical studyThe U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in…
- FDA to appoint permanent heads of CBER and CDER alongside new commissionerThe FDA is preparing to announce a series of senior leadership changes concurrent with the appointment of a new commissioner. Among the planned announcements are permanent appointments for the hea…