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The Senate Appropriations Committee has released the draft of a bill that would grant the FDA $3.2 billion in fiscal 2021 funding — an amount that mirrors what the House allocated in July and is in line with the Trump administration’s budget request for the agency. Read More
Democrats in both the House and Senate have penned letters to the Department of Justice protesting its $8.3 billion settlement with Purdue Pharma that would see the beleaguered opioid maker become a public benefit company as it emerges from bankruptcy over its role in the opioid crisis. Read More
The head of the Butantan Institute, which is leading the trial, does not believe the adverse event is related to the vaccine, Sinovac claims. Read More
The UK’s National Institute for Health and Care Excellence (NICE) is considering changes to how it evaluates the cost-effectiveness of medicines and is inviting public comment. Read More
Rick Bright, who was leading the vaccine effort at NIH’s Biomedical Advanced Research and Development Authority (BARDA) but was pushed aside by the Trump administration, has joined President-Elect Joe Biden’s Transition COVID-19 Advisory Board. Read More
As Novavax gears up to put its investigational COVID-19 vaccine through a phase 3 U.S. trial this month, the FDA has granted the candidate a Fast-Track designation in order to speed up its regulatory review process. Read More
Regulatory approval “should be based on an independent scientific assessment of the balance of benefits and risks,” the joint statement said. Read More
The FDA has published final guidance designed to help drug compounders recognize, prevent and respond to insanitary conditions at their facilities. Read More