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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the process for a generic drug facility to request a meeting to discuss deficiencies outlined in a warning letter, in a draft guidance released Friday.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
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
Over the past week, the FDA issued guidance on its intention not to take action to enforce the requirements of DSCSA until Nov. 27, 2024, recommendations on system attributes necessary to enable secure tracing of products at the package level under DSCSA, formal dispute resolution on pharmaceutical GMP scientific and technical issues, and use of real-world data to support regulatory decision making. Read More