Category: Pharmacovigilance

Govzilla’s Top 20 Posts of All Time

To serve as a resource for you and your company and to help orient you to the scope of the Govzilla blog, we assembled a list of some of our most useful, relevant, and popular articles of all time.

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Part 3: MHRA GMP Inspection Deficiencies for 2018

Published in late 2019, MHRA’s 2018 GMP inspection deficiency data spans over 6,000 lines of a spreadsheet. GMP expert Barbara W. Unger evaluated the data and presents a data-dense report of her findings and deficiency trends since 2015.

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Part 2: MHRA GMP Inspection Deficiencies for 2018

Published in late 2019, MHRA’s 2018 GMP inspection deficiency data spans over 6,000 lines of a spreadsheet. GMP expert Barbara W. Unger evaluated the data and presents a data-dense report of her findings and deficiency trends since 2015.

Read More »

Part 1: MHRA GMP Inspection Deficiencies for 2018

Published in late 2019, MHRA’s 2018 GMP inspection deficiency data spans over 6,000 lines of a spreadsheet. GMP expert Barbara W. Unger evaluated the data and presents a data-dense report of her findings and deficiency trends since 2015.

Read More »

FDA Warning Letters Week of 3/1/2020: Device Design Controls, HCT/P

Enforcement this week included a collection of warning letters including three device warning letters and three drug GMP warning letters, including one to a fertility clinic governed under 21 CFR 1271. And, warning letters to firms touting treatments for the coronavirus disease finally started appearing.

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Part 2: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries

This report provides an in-depth look at recent activities by the Consumer Protection Branch of the Department of Justice in the drug enforcement space. While FDA has its own enforcement tools, CPB gets involved if those tools fail to bring bad actors into compliance, which happened several times in 2019.

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Part 1: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries

This report provides an in-depth look at recent activities by the Consumer Protection Branch of the Department of Justice in the drug enforcement space. While FDA has its own enforcement tools, CPB gets involved if those tools fail to bring bad actors into compliance, which happened several times in 2019.

Read More »

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