Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems,...
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Combination Products Challenge Regulators and Manufacturers
Combination drug products are high on everyone’s radar screen, as seen in continuing discussion about appropriate testing and regulation of self-injectors, such as EpiPen,...
Brief from PDA workshop on FDA Guidance for Process Validation
BRIEF FROM THE PDA WORKSHOP ON FDA’S NEW GUIDANCE ON PROCESS VALIDATION “THE SHIFTING PARADIGM IN PROCESS VALIDATION” OCTOBER 26-27, 2009 (10/31/2009)...