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.
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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.
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
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.
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.
Omnicell
JANUARY 10, 2023
Hospitals are already using Fresenius Kabi Simplist® MicroVault® prefilled syringes to help nurses spend less time preparing doses and documenting waste. The new cassettes for the Omnicell CSD will accommodate MicroVault® packaging for a variety of low-dose narcotic medications, including morphine, hydromorphone, and fentanyl.
Expert insights. Personalized for you.
57 
Let's personalize your content