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USP General Chapter —Glass revised

European Pharmaceutical Review

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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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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Halting Europe’s essential medicines manufacturing exodus

European Pharmaceutical Review

The recent update to the EC Urban Waste Directive, part of the environment package ‘Towards Zero Pollution,’ 4 has a disproportionate producer responsibility principle that will incur considerable extra costs. Available at: [link] Teva Pharmaceuticals Europe ‘Addressing Europe’s Essential Medicines Exodus’ 2022.

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FDA Issues Long-Awaited QMSR Final Rule

The FDA Law Blog

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different. The new § 820.10

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

The FDA Law Blog

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.

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MSD secures full approval for Keytruda’s use in MSI-high solid tumours

Pharmaceutical Technology

In 2022, the company reported Keytuda sales of $20.9 billion in its FY 2022 results. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials. billion in 2028. GlobalData is the parent company of Pharmaceutical Technology.

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A PSA on PSGs: PSG Meetings Are Now Available

The FDA Law Blog

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.

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