2020 Documentation Packaging 
European Pharmaceutical Review
AUGUST 23, 2022
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.
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.
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Pharmaceutical Technology
JULY 15, 2022
The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.
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.
pharmaphorum
FEBRUARY 10, 2021
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.
European Pharmaceutical Review
FEBRUARY 2, 2023
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.
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.
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