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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

Indeed, a 2020 operation coordinated by Europol across 27 countries led to the seizure of more than 25 million units of counterfeit anticancer drugs and erectile dysfunction medicines among other fake drugs worth nearly €73 million. One area in which the problem can be tackled effectively is product packaging.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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EU-funded project encourages use of simulation in drug development

pharmaphorum

The project is coordinated by the University of Bologna and funded by the European Union’s Horizon 2020 research and innovation programme that involves more than a dozen partner institutions, including Italian startup InSilicoTrials.

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What is cross contamination in pharmaceutical industry

GMPSOP

Cross contamination is dangerous in pharmaceutical industry as it can severely compromise patient safety if the content is not pure and the product package differs from what is written on the label. – According to WHO report on 20 th April 2020, 1 in 10 people fall ill after eating contaminated food worldwide.

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Halting Europe’s essential medicines manufacturing exodus

European Pharmaceutical Review

Between 2000 and 2020, Asian companies outperformed European companies for new approvals of CEPs, increasing their number CEPs from 183 to 2,369. References European Commission Staff Working Document ‘Strategic Dependencies and Capabilities’, update to the 2020 New Industrial Strategy, 2021.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog: Biosimilars

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). Attachment number) and document name or description as appropriate.