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.
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. Stellpflug S.J., & Kerns II W (2019). Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Intensive care medicine , 33 (11), 2019–2024. Greene et al., References.
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The People's Pharmacy
MAY 8, 2023
In fiscal year 2019, the year before the COVID-19 pandemic limited travel and movement, the FDA inspected 37% of the nearly 2,500 overseas manufacturers; in 2022, the agency only inspected 6% of around 2,800.” According to ProPublica, the FDA visited 45% of the pharmaceutical plants there in 2019.
Pharmaceutical Technology
MARCH 30, 2023
There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials. While the drug was granted accelerated approval in June 2019, it did not deliver on a key overall survival (OS) endpoint as part of its post-marketing data package.
pharmaphorum
AUGUST 16, 2021
Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials. In 2019, Formedix collaborated with a UK-based consortium interested in observing early safety data. This gives great risk for human error and misinterpretation.
Omnicell
JANUARY 10, 2023
In 2019, more than 148 million doses of medicine were lost , endangering both patients and employees. And according to the 2019 Drug Diversion Digest , 47.2 Hospitals are already using Fresenius Kabi Simplist® MicroVault® prefilled syringes to help nurses spend less time preparing doses and documenting waste.
ISPE
MAY 11, 2023
The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Pharmaceutical Engineering (May/June 2019).
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