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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”…

Read more

Is Mandatory Dietary Supplement Product Registration Coming?

From Jennifer Grebow of Nutritional Outlook, industry experts believe dietary supplement product registration could be incoming. One attorney that assisted in drafting the Dietary Supplement Health and Education Act of 1994 (DSHEA) noted that the industry is moving towards a…

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Important Lessons from the FDA’s Kratom Salmonella Probe

Back in February, many kratom manufacturers recalled products due to Salmonella contamination. The outbreak occurred across 41 states with 199 individuals hospitalized per the Centers for Disease Control (CDC). While the outbreak is on the smaller side, the Food and…

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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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