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
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the process for a generic drug facility to request a meeting to discuss deficiencies outlined in a warning letter, in a draft guidance released Friday.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
After dropping its challenge to the proposed transaction last week, the FTC will allow Amgen’s $27.8 billion buyout of Horizon Therapeutics to proceed under terms set in a consent order — while six state attorneys general also announced they will dismiss their challenges to the deal. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) seeks to dispel “possible misconceptions” about its proposed quality management maturity (QMM) system in a new white paper. Read More