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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the process for a generic drug facility to request a meeting to discuss deficiencies outlined in a warning letter, in a draft guidance released Friday.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
AdvaMed and the Medical Device Manufacturers Association (MDMA) commented this week on a CMS notice expediting Medicare coverage of emerging technologies, urging swift acceptance of the program, but also arguing that the proposal is limited in nature and doesn’t cover enough innovative devices. Read More
Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) want the FDA to close loopholes that keep generic drugs off the market, they said in a recent letter to FDA Commissioner Robert Califf. Read More
After inquiries about food, the FDA Office of the Ombudsman hears most often from device companies — because there are more small companies in that area of the industry — and they need help to solve a problem they’re having with the agency, said office director Laurie Lenkel during an Alliance for a Stronger FDA webinar Wednesday. Read More
Novo Nordisk has acquired Embark Biotech, as the larger Danish drugmaker looks to expand its blockbuster obesity drug portfolio in the wake of surging economic demand and rising market shortages of both metabolic and diabetes therapies. Read More