CGMP/Finished Pharmaceuticals/Adulterated
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Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation
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FDA Listing of Authorized GenericsMAMTAKIM Inc Recalls Dried Whole Smelts Salted (KORUSHKA) Because of Possible Health Risk
MAMTAKIM Inc, located at 888 Magnolia Ave, Elizabeth, NJ 07201, is recalling Item # LL0320 DRIED WHOLE SMELTS SALTED (KORUSHKA), 5.29 oz (150 g) / 20 – 1 box, because this product consists of dried, un eviscerated fish longer than 5 inches, which has the potential to be contaminated with Clostridium
