The FDA Law Blog
APRIL 8, 2025
Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.
Hospital Pharmacy Europe
JULY 1, 2025
In response to this, the Leeds Teaching Hospitals NHS Trust (LTHT) pharmacy team has recently launched its ‘Digital Induction’ document. Initial feedback has been overwhelmingly positive, leading to the creation of additional documents tailored for line managers and pharmacy students with specific digital needs.
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STAT
MARCH 7, 2025
The sprawling conglomerate — which owns a major health insurance company, physician practices, a pharmacy benefit manager, and numerous other firms — acquired or created more than 250 subsidiaries in 2024. And just like in 2023, UnitedHealth has prioritized outpatient surgery centers.
The FDA Law Blog
JANUARY 9, 2025
Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).
The FDA Law Blog
JULY 8, 2025
Per FDA’s update, non-application products without annual report requirements should prepare similar documentation and retain it for FDA inspection requests. See FDA, Guidance, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) at 4 (Aug. Such action would provide little public benefit.
European Pharmaceutical Review
JUNE 19, 2025
Document 9286/25. The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. Streamlined Approval of Biosimilars: Moving On From The Confirmatory Efficacy Trial. 2020;25(11):1910-1918. Biosimilar Medicines: Overview.
Hospital Pharmacy Europe
JULY 23, 2025
This, in turn, requires structured documentation, such as dedicated fields in electronic prescribing systems, where prescribers can specify critical preferences like flavour, texture or excipient restrictions, to ensure that each patient receives a safe and personalised formulation. Int J Pharm X 2024 Dec;8:100277. 14 Awad A et al.
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