FDA Record Review Results in Warning Letter for OTC Drugmaker
The FDA has exercised its new authority to use remote records reviews in lieu of certain types of GMP inspections, issuing a warning letter to Green Pharmaceutical of South Korea…
PEAC Committee Offers Device Design Advice to CDRH
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…
EU GMP Report — September 2023
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
LightStrike+ UV Broad Spectrum Robot Gets FDA De Novo Clearance for Disinfection
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
FTC/DOJ Merger Guidance Still Lacking, Say Panel Members at Workshop
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,…
FDA Aims to Modernize 510(k) Device Program in Trio of Draft Guidances
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 Sued for Disclosing HIPAA Protected PII and PHI to Google and Others
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…
Meeting Planner — Sept. 4, 2023
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 Joins Fight Against IRA With Lawsuit Challenging Constitutionality
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
Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines
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…