2022 Documentation Packaging 
European Pharmaceutical Review
APRIL 8, 2025
Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.
European Pharmaceutical Review
SEPTEMBER 2, 2022
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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European Pharmaceutical Review
FEBRUARY 2, 2023
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.
FDA Law Blog: Biosimilars
FEBRUARY 21, 2024
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
FDA Law Blog: Biosimilars
JULY 10, 2023
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.
European Pharmaceutical Review
JANUARY 25, 2024
These standardised documents provide meticulously curated and scientifically approved information. 2017) “Danmark har flest smartphones i hele verden”, Berlingske, Eurostat (2022) “Medicine Use Statistics” European Commission. Eurostat (2022) “Internet access and use statistics – households and individuals.”
Pharmaceutical Technology
MARCH 30, 2023
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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