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In this edition of Quick Notes we tackle regulatory activity across the pond in Britain and the EU with stories on increased EMA fees, electronic product information for medicines, an updated service to help pharmaceutical companies and repurposing of a drug to help prevent breast cancer. Read More
The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections Summit last week. Read More
The FDA has extended the effective date of the guidance “COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers” until Aug. 7, 2024, unless a revised final guidance is issued before that date. Read More
This edition of Quick Notes highlights the outcome of an adcomm on a device to eliminate cancer cells from blood collected during surgery, the FDA’s acceptance of a medical device cybersecurity consensus standard, and two post-market studies of cardiac device efficacy.Read More
The FDA’s final guidance on real-time oncology review (RTOR) — a program intended to facilitate review of NDAs — advises sponsors to submit in modules, at different times, enabling an earlier start to the application review process. Read More
The FDA wants its Radiological Devices Advisory Panel to weigh in on whether irradiators used to prevent metastasis in salvaged blood during cancer surgeries are safe enough to be classified as Class II devices or whether, as the FDA proposes, they should be designated as high-risk Class III devices requiring premarket approval. Read More
The FDA is also proposing to exempt certain clinical electronic thermometers without telethermography from premarket notification requirements. Read More
With the looming expiration of temporary government funding on Nov. 17, lawmakers face significant challenges to reconciling the House and Senate versions of fiscal 2024 appropriations bills — including one to fund the FDA. Read More
In a guidance set to go into effect immediately, the FDA has made permanent the enforcement policy for use of clinical electronic thermometers it set during the COVID-19 public health emergency. Read More