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Alex Azar, President Trump’s nominee for Secretary of Health and Human Services, emphasized his view that “drug prices are too high” to the Senate Finance Committee, even as Democrats continued to ask about his role in drug cost increases at Eli Lilly when he served as its president. Read More
Australia’s Therapeutic Goods Administration issued revised guidelines for its comparable overseas regulators (CORs) program, designed to collaboratively regulate prescription medicines using an international report-based process. Read More
Testifying before a UK House of Commons committee last month, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making preparations for new hurdles in manufacturing and duplications of batch release testing that could cost millions of pounds per year. Read More
The European Medicines Agency and the European Commission broadened their guidance on Brexit to include new information for manufacturers of orphan drugs, generics and biosimilars, as well as hybrid medicines that rely on reference product data as well as new clinical trial findings. Read More
The European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines this year, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
The Patient Engagement Collaborative is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between the FDA and Duke University. Read More
The European Medicines Agency adopted the International Council for Harmonization E7 guideline on multi-region clinical trials, which can support simultaneous product submissions in different parts of the world and more efficient drug development. Read More
The FDA issued Imprimis Pharmaceuticals a warning letter after finding the firm made misleading claims about its eye care products on its website and social media, saying the violations created a public health concern. Read More
The federal government’s guidance for monitoring opioid use among Medicare beneficiaries does not go far enough in identifying which beneficiaries are most at risk and the Centers for Medicare & Medicaid Services should collect data on exactly how many at-risk beneficiaries receive high doses, according to a new GAO report. Read More
Enabling access to medical countermeasures for material threats is a top FDA priority, according to Commissioner Scott Gottlieb, who reviewed the agency’s efforts before a Senate committee Wednesday. Read More
The federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to take effect Jan. 19 — and warned the public to expect additional delays down the line. Read More