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The European Medicines Agency published new, practical guidance for marketing authorization holders in navigating the UK’s 2019 departure from the European Union — including the procedures for classifying any Brexit-related impacts on pharmaceutical manufacturing. Read More
The FDA received a wide range of comments and questions Monday at a public meeting to receive comments on a discussion document on patient-focused drug development — an early draft for the agency’s planned series of guidances on the topic. Read More
The European Medicines Agency and the European Network for Health Technology Assessment released a joint work plan to help medicine developers improve clinical research and become more efficient in generating the evidence needed for both agencies. Read More
The FDA issued two draft guidances to encourage using the 510(k)-Clinical Laboratory Improvement Amendments (CLIA) waiver dual application pathway for new in vitro diagnostic devices, and to update its policies for demonstrating accuracy to obtain a CLIA designation. Read More
A new requirement has been added to the FDA’s Reviewer Certification Program — training in the development, evaluation and use of patient-reported health outcomes, the agency said in its first report on PROs in medical device premarket submissions and post-market studies. Read More
The FDA issued final guidance explaining the new framework the agency will use when assigning IDE devices to one of two categories prior to clinical studies — Category A: Experimental and Category B: Nonexperimental/investigational. Read More
China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to remove barriers to expediting reviews. Read More
A workers’ benefits fund filed a lawsuit claiming Johnson & Johnson maintained an illegal monopoly for its blockbuster drug Remicade, employing anticompetitive schemes involving insurer contracts, rebate protocols and bundling. Read More
Under a new category of generic ANDAs eligible for priority review, the FDA will prioritize applications likely to be ready for approval shortly after the six months of marketing exclusivity that is awarded to a first-to-file generic drug. Read More
The Hatch-Waxman amendments did not strike a good balance between generic access and brand-name innovation, according to public comments to the FDA from both PhRMA and the Association for Accessible Medicines — however the two groups disagree as to how. Read More
The FDA published a draft guidance explaining the new biosimilar fee structure under BsUFA II and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay and how to request reconsiderations of fee assessments. Read More