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The FDA is seeking feedback on a discussion paper focused on using AI and machine learning (ML) in drug development as well as in the development of medical devices intended to be used with drugs. Read More
Four bills aimed at encouraging drug development and controlling costs survived markup by the Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday, lining them up for consideration and vote by the full chamber. Read More
A U.S. District Court in Illinois has ordered Eli Lilly to pay triple damages — $183.7 million — for violating the False Claims Act by underpaying rebates to Medicaid. Read More
Senators from both sides of the aisle pressed insulin makers and pharmacy benefit managers (PBM) on the drug’s high cost during a committee hearing Wednesday, where the two groups accused each other of driving up costs and lawmakers often appeared baffled by the opaque schemes of drug pricing. Read More
Gilead Sciences has prevailed in what appears to be the first lawsuit filed by the U.S. government against a drugmaker in an attempt to enforce patent rights, dodging an almost $1 billion payout. Read More
Multiple unaddressed violations of current good manufacturing practice, FDA regulations and noncompliance with a 2012 consent decree have earned India’s Sun Pharmaceutical a hefty list of corrective actions to complete before resuming drug exports to the U.S. Read More
The FDA has issued a final guidance to help manufacturers prevent the use of glycerin and other high-risk drug components contaminated with the toxic substances diethylene glycol (DEG) or ethylene glycol (EG), to combat a rise in fatal consumer poisonings. Read More
CDER’s Office of Pharmaceutical Quality (OPQ) Director Mike Kopcha leads an office of more than 1,300 staff involved in assessing drug marketing applications. FDAnews asked him about OPQ’s challenges, priorities and goals. Read More
A new document from the Medical Device Single-Audit Program (MDSAP) outlines the program’s plan for implementing its Quality Management System (QMS) guidance on how to design, strengthen and develop quality management processes, products, outcomes and services. Read More
Federal funding of clinical studies often goes unreported — or is reported inaccurately — when drug manufacturers apply for patents, says a new report from the Government Accountability Office (GAO) that points the finger at the National Institutes of Health’s (NIH) failure to enforce reporting requirements. Read More
Changes in the user fee program as a result of the Prescription Drug User Fee Amendments of 2022 (PDUFA VII) are detailed in a new FDA final guidance issued on Friday. Read More