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As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Read More
The rising obesity rate in the U.S. could foil Perrigo’s bid to offer the U.S.’s first OTC oral contraceptive, according to FDA briefing documents in advance of a two-day advisory committee meeting this week. 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
The European Medicines Agency (EMA) is seeking public comment on its transparency rules and protection of personal and commercially confidential data submitted to its clinical trials database. Read More
Over the past week, the FDA issued several guidance documents — including a final guidance on developing nicotine replacement therapy drug products, a final guidance on quality risk management and a draft guidance on decentralized clinical trials for drugs, biological products and devices. Read More
In a Senate hearing on reauthorization of the 2006 Pandemic and All-Hazards Preparedness Act (PAHPA), FDA Commissioner Robert Califf reiterated the agency’s call for better data and more supply chain notification authority to prevent future drug and medical device shortages. Read More
Despite more than half of treated patients developing adverse reactions, Eli Lilly will seek a traditional full approval for donanemab after topline phase 3 data showed that the antiamyloid antibody prevented further cognitive decline in 47 percent of early-stage Alzheimer’s patients and slowed decline by up to 36 percent on two other scales. Read More