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InstantGMP™ Release Notes for Version 3.009.001

New Functionalities Like MPRs, BPRs now have a “view only mode” of their Manufacturing Instructions. This “view only mode” appears after the BPR has been Reviewed, Rejected or Added to Inventory. Each Manufacturing Instruction step in a BPR is “locked”…

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InstantGMP™ Release notes for version 3.009.001

New Functionalities Like MPRs, BPRs now have a “view only mode” of their Manufacturing Instructions. This “view only mode” appears after the BPR has been Reviewed, Rejected or Added to Inventory. Each Manufacturing Instruction step in a BPR is “locked”…

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FDA’s Biosimilar Action Plan

In a recent press release, Food and Drug Commissioner Dr. Scott Gottlieb explained the agency’s plan for improving access and competition for biosimilars. Dr. Gottlieb’s emphasis on diversifying biosimilars comes as the FDA continues to strengthen the Biologics Price Competition…

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