We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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
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 need greater detail. Read More
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) in a final guidance issued Tuesday. Read More
The FDA spells out the process for a generic drug facility to request a meeting to discuss deficiencies outlined in a warning letter, in a draft guidance released Friday. Read More