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This edition of Quick Notes highlights a permanent injunction against a manufacturer of dietary supplements, request for improved post-market evidence standards, a study on lessening cyber threats to legacy devices, drug distribution partners going all-electronic and seeking input on pulse oximeter discrepancies. Read More
Companies that make pharmaceutical, biologic and medical devices are caught hiding relevant information or purposefully delaying applying for patents at the U.S. Patent & Trademark Office (USPTO) in gamesmanship moves that occur in the medical field far more than in other industries, according to recent reports. Read More
An uncontrolled arm that rotated after operation stopped caused Asensus Surgical’s recall of its Senhance surgical system, which has been identified by the FDA as a class I recall, the most serious type of recall, because use of these devices may cause serious injuries or death. Read More
In this edition of Quick Notes, we review marketing authorization for chlamydia and gonorrhea at-home sample collection kits, FDA guidance on notifying the agency of device discontinuances or interruptions, assessing the credibility of computational modeling and simulation, as well as class I recalls of Fresenius syringes and Baxter syringe pumps. Read More
After almost a decade devoted to implementing unique device identifier (UDI) regulations, the FDA is now focused on enforcing them, says UDI expert Jay Crowley, a former FDA official who played a key role in crafting the U.S. regulations. Read More
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