2021 Documentation Packaging 
The FDA Law Blog
DECEMBER 8, 2022
Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. All packaged foods served or sold on transportation carriers (e.g., After reviewing comments, FDA will revise and move questions and answers to the final document, as it deems appropriate.
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.
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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.
The FDA Law Blog
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.
Pharmaceutical Technology
MARCH 30, 2023
In August 2021, MSD was able to convert Keytruda’s accelerated approval for its use in in patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-based chemotherapy, into a full approval. As per GlobalData’s consensus forecasts, the drug is estimated to yield global sales of $34.79
ISPE
MAY 9, 2023
Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.
The FDA Law Blog
MARCH 27, 2023
Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.
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