FDA Unveils Adverse Event Reporting Rules For Combination Products
FDA says its proposed adverse event reporting requirements for combination products will help manufacturers navigate the intricate array of reporting requirements for deaths and injuries
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FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials