pharmaphorum
FEBRUARY 10, 2021
It will also produce policy documents and information packages for patients, doctors and senior management in companies, Other workstreams could include computational strategies to make such simulations more powerful and efficient, new curricula to educate the workforce on the development and use of the technologies.
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.
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Pharmacy Friday Pearls
AUGUST 29, 2022
2018 Retrospective chart review at a regional poison center (n=199) Patients identified in database by searching for “Beta Blockers”, and/or “Calcium Channel Antagonists” and “insulin” in the respective fields. mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET.
European Pharmaceutical Review
NOVEMBER 24, 2022
One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.” percent to as low as 0.20
The People's Pharmacy
MAY 8, 2023
“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” There have been problems with records in the past: deceit, falsification of documents and even outright fraud.
The FDA Law Blog
SEPTEMBER 26, 2022
FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. much like an FDA guidance document. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. FDA must also review the list periodically.
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. Many organizations already have documented process maps.
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