Will Biosimilars Lead To Better Biologics Manufacturing?
US FDA Commissioner Gottlieb is promising new policies to improve biologics manufacturing as part of agency’s action plan to accelerate biosimilar development. That follows the pattern set 25 years ago with generic drugs and brand manufacturing.
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WARNER-LAMBERT FAJARDO, P.R. PLANT TO BE TAKEN OFF FDA INTEGRITY POLICY SOON, FIRM SAYS; FAILURE TO REPORT DILANTIN TEST FAILURES PROMPTS GUILTY PLEA
Warner-Lambert's Fajardo, P.R. plant will be cleared under FDA's application integrity policy in the near future, the company said following its guilty plea in a case stemming from failure to report stability failures of drugs, some of which were manufactured in the plant.
Health Canada has licensed Hugo for urologic and gynecologic laparoscopic surgical procedures.