Device manufacturers should be more conscious of potential demographic bias in clinical trials, which could show up as differences in safety, effectiveness or ease of use, according to members of…

This month’s feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Source: Drug Industry Daily

Creating a new medical device classification, the FDA has granted Xenex Disinfection Services’ LightStrike+ high-intensity, broad-spectrum ultraviolet (UV) light robot a De Novo marketing authorization. Source: Drug Industry Daily

The 13 new draft guidelines focused on mergers and acquisitions from the FTC and the Department of Justice (DOJ) go into a lot of detail about what constitutes anticompetitive practices,…

The FDA published three draft guidances Wednesday seeking to modernize the 510(k) pathway and help manufacturers navigate the premarket review process as medical devices become increasing complex and innovative. Source:…

Medtronic MiniMed has been accused of transmission and disclosure of HIPAA protected personally identifiable information (PII) and protected health information (PHI) from its InPen diabetes management system to Google, Crashlytics…

Upcoming events in the coming weeks include nine FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual…

Novartis has joined the chorus of pharma voices claiming the Inflation Reduction Act’s (IRA) Medicare Part D drug price negotiation provision exceeds Congress’s lawful authority. Source: Drug Industry Daily

Four major industry groups shared their thoughts on the International Council for Harmonization’s E6(R3) draft GCP guidelines, commenting on stakeholder engagement, diversity, service provider evaluations and pointing out areas that…

The FDA recommends that “trading partners” use the Electronic Product Code Information Services (EPCIS) standard — developed by GS1 — for compliance with the Drug Supply Chain Security Act (DSCSA)…