Drug Industry Daily

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: Drug Industry Daily

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 therapy for a severe form of type 1 diabetes. Additionally, the FDA approved a new device for skin repigmentation in patients with vitiligo. Source: Drug…

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 Council on Harmonisation and issued for comment by the European Medicines Authority (EMA). Source: Drug Industry Daily

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 in inspectional coverage and the effective and efficient use of FDA resources to address the most significant public health risks.” Source: Drug Industry Daily

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 that, while developed quickly, are of high quality, safe and proven effective, and that include input from patients, providers and payers early in the process.…

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 published Wednesday in JAMA Open Network.. Source: Drug Industry Daily

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 a spike in drug shortages. Source: Drug Industry Daily

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 dismiss in a case that also involves exclusive-dealing. Source: Drug Industry Daily

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 two ingredients in the NDA. Source: Drug Industry Daily

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 control. Source: Drug Industry Daily