The first wireless pulse-oximetry device for infants has received an FDA 510(k) clearance after first receiving a warning letter for selling the device without the agency’s clearance or approval. Source:…

New FDA drug approvals in June include new gene therapies for ambulatory Duchenne Muscular Dystrophy and hemophilia A, a treatment for pediatric growth hormone deficiency and the first ever cell…

Use of real-world data (RWD) and real world evidence (RWE) continues to gain traction in countries around the world, as seen in a draft reflection paper endorsed by the International…

The FDA has updated how the Office of Pharmaceutical Quality (OPQ) will select manufacturing sites for routine surveillance inspection, using information about the compliance history of sites “to promote parity…

CDRH’s new development initiative — Total Product Life Cycle Advisory Program (TAP) — taps into an FDA goal: to ensure U.S. patients are first to benefit from innovative medical devices…

Nearly 20 percent of AI and machine learning (ML) devices in a study had discrepancies between FDA-cleared indications for use and information included in marketing materials, according to a report…

The Association for Accessible Medicines (AAM) says that the “looming” Nov. 27 Drug Supply Chain Security Act deadline requiring interoperable exchange, verification and tracing for all drug products, could cause…

The FTC’s amicus brief in a product-bundling case has “broad implications for antitrust enforcement in the healthcare sector and beyond,” the FTC says, regarding its analysis of Medtronic’s motion to…

Amneal Pharmaceuticals’ recent complete response letter (CRL) for its investigational Parkinson’s extended-release drug IPX203 didn’t identify any issues with efficacy or manufacturing — just the safety of one of the…

Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI Clinical Research Conference and webinars on the FDA’s sterilization pilot and design…