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The International Generic Drug Regulators Programme released guidance for quality assessors in regulatory agencies on the preparation of quality assessment reports, and noted the guidance may be useful for anyone responsible for the preparation of quality information submitted to regulatory agencies. Read More
President Trump’s nominee for the next secretary of HHS, former Eli Lilly executive Alex Azar, told the Senate’s health committee he agrees prescription drug prices are too high, and would welcome congressional action if appointed to the post. Read More
The UK government announced a long-term strategy for the nation’s industries, including a multi-billion pound initiative to boost investment in the life sciences sector. Read More
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
The FDA is using President Trump’s mandate to shrink the size of the government’s regulatory footprint as an opportunity to re-examine how its rules may be misused to delay generic competition — and to clear the decks of older regulations that advances in science have made obsolete, a senior HHS official told lawmakers. Read More
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