Combination drug products (i.e., products that are a combination of a medical device and/or a drug and/or a biologic) are inherently complex to...
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Mass Spec Weighs In on Protein Therapeutics
Proteins—especially antibodies—are gaining in popularity in the pharmaceutical industry, both as drugs in their own right and as targeting agents for other drugs. In fact,...
A New Day for Process Validation and Regulatory Review
New drug approval and validation strategies are needed for Fast Track, Breakthrough Therapy and Accelerated Approval drugs. A new Pharmaceutical Manufacturing article,...
Medical Device Process Validation
Medical Device Quality Systems Manual Medical Device Process Validation Quality Management Systems – Process Validation Guidance The Global Harmonization Task...
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)...
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