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In a recent court filing, HHS lambasted the U.S. Chamber of Commerce’s recent call to slow down implementation of pricing negotiations within the Inflation Reduction Act (IRA), calling the group’s efforts “hyperbolic” and accusing it of just trying to lobby Congress in court to stop the Act’s efforts to drive down the cost of prescription drugs. Read More
This first European Edition of Quick Notes includes a PDUFA date extension for a chikungunya vaccine candidate, NICE approved AI technologies for radiotherapy treatment therapies, Novartis cited for claims made on an Entresto podcast and comments on the EU proposal for compulsory licensing. Read More
Oncopeptides is appealing a formal request from the FDA to withdraw its blood cancer therapy drug Pepaxto (melphalan flufenamide) as the agency flexes its newfound regulatory authority for pulling drugs that receive an accelerated approval but fail confirmatory studies. Read More
PhRMA, the National Infusion Center Association and the Global Colon Cancer Association have filed a motion for summary judgment — a final decision made by a judge without going to trial — in their case against HHS over the Inflation Reduction Act’s (IRA) drug price negotiation program. Read More
More than 60 percent of the drugs approved last year won their FDA nod on the basis of a single clinical trial that was conducted by the drug sponsor, a new analysis has determined. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
In July, the court said that PTAB used incorrect legal framing and conducted an erroneous obviousness analysis in its opinion on separate but related Medtronic patents. Read More
Quick Notes
Today’s Quick Notes include a drug shortages survey conducted by the American Society of Health-System Pharmacists, an AARP analysis of drug price increases and a request for comments from the FDA on the development of a technology and software assessment that examines the feasibility of dispensers to meet new requirements. Read More
The complex process of regulating combination products begins with the FDA’s determination of which center — CDRH, CBER or CDER — will take the lead role in overseeing a product’s development, but even after that determination is made, the way regulations are applied opens up another layer of complexity. Read More
Over the past week, the FDA issued final guidance on acceptable intake limits for nitrosamines and draft guidances on QTc information in human prescription drug and biological product labeling, classification categories for biosimilars, formal meetings for biosimilars and postmarketing approaches in clinical trials. Read More