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The price reduction measures in the Inflation Reduction Act (IRA) could result in 79 fewer small molecule drugs or 188 fewer indications and 116 million life years lost over the next 20 years, a study funded by Gilead Sciences revealed. Read More
In a new final guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’”, the FDA provides information on using ISO 10993-1 for evaluating devices that come into direct contact with intact skin, including the types of information that should be included in premarket submissions. Read More
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 based on a review of records it requested on March 3. Read More
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 the FDA’s Patient Engagement Advisory Committee (PEAC). Read More
This month’s feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG.Read More
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. Read More
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, but they don’t do enough to tell companies what is acceptable when they’re planning a merger or acquisition. Read More
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. Read More
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 and other tracking tools. Read More
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 Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities and medical device counterfeiting. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking public feedback on a plan that would end regulatory reciprocity between the UK and the EU for drug and device review and approvals. Read More
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. Read More