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The FDA’s latest biosimilar user fee negotiations with industry representatives focused on the agency’s proposals for a regulatory science pilot program and guidance on biosimilar interchangeability, as well as furthering discussions on several other topics. Read More
President Biden’s request for an additional $343 million in FDA budget authority for fiscal 2022 has been met with enthusiasm by the Alliance for a Stronger FDA, which lauds the proposed boost in agency funds but cautions that Congress could become entangled in debates about caps for overall federal funding this year. Read More
Six states have passed laws to create importation programs that aim to lower costs by procuring cheaper foreign drugs, but the states need the FDA’s approval before they can implement their plans. Read More
A controversial bankruptcy settlement is moving forward in the sprawling opioid litigation against Purdue Pharma despite fierce resistance from dozens of attorneys general. Read More
With a Drug Supply Chain Security Act (DSCSA) implementation date set for 2023, the FDA has published four guidances designed to bolster efforts to identify and trace drugs as they move through the supply chain, including a final guidance clarifying product identifier requirements for drugmakers. Read More
The FDA gives advice for in vitro testing and labeling of oral drugs intended to be given by enteral tube in a draft guidance released yesterday, noting that in vitro testing prior to clinical studies will help identify any product-specific risks. Read More
At the behest of Congress, the Federal Trade Commission (FTC) has issued a report on a drug industry tactic that involves leveraging rebates to block competing products, suggesting that the agency may be viewing the anticompetitive practice as a growing area of concern. Read More
The agency noted that it is illegal to advertise that a drug can treat a disease unless it is approved based on “competent and reliable scientific evidence,” but no such study is currently known to exist for the products in question. Read More
Moderna has begun its bid for full U.S. approval for its COVID-19 vaccine in the hopes of advancing it beyond Emergency Use Authorization (EUA) status. If regulators grant the request, it will allow the company to market the vaccine directly to consumers and would mark Moderna’s first approved product for the coronavirus. Read More
World Trade Organization (WTO) negotiations resumed Monday over a revised version of a controversial proposal to temporarily waive patents for COVID-19 products, including vaccines and therapeutics. Read More