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This edition of Quick Notes highlights a major supplier’s data breach, good news for wearable defibrillator and renal denervation devices, and labeling to remind surgeons about nonapproved mesh products. Read More
Reorganization of two of the FDA’s larger offices in 2024 will bring about changes in how the agency handles inspections and drug assessments. Read More
When the rare disease patient community was seeking to have the FDA pay more focused attention to orphan drugs, they asked Janet Woodcock for support. She established within CDER a new office dedicated to orphan drugs and rare diseases. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
The FDA has deemed B. Braun recall of its Space Volumetric Infusion Pump System due to a potentially faulty occlusion alarm that can stop the delivery of medications as class I, the most serious type of recall as use of the device can cause serious injury or death. Read More
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
Over the past week, the FDA issued final guidance on assessing credibility of computational modeling and simulation in medical device submissions and notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under section 506J of the FD&C Act. Draft guidance was issued on select updates for the 506J guidance and product specific guidances for drugs. Advisory committee meetings were announced for multi-cancer detection devices, pulse oximeters and the 506J devices list. Read More