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.
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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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.
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.
Roots Analysis
FEBRUARY 1, 2024
Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.
European Pharmaceutical Review
JANUARY 25, 2024
These standardised documents provide meticulously curated and scientifically approved information. Eurostat (2022) “How many citizens had basic digital skills in 2021?” Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety.
Pharmacy Friday Pearls
AUGUST 29, 2022
mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. 2021, December 17). Greene et al., units/kg/hr) Euglycemia was maintained using 5-10% dextrose infusions. Beta Safe Than Sorry!
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