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The Veteran’s Health Administration (VHA), working with the FDA and several other agencies, has launched a challenge for the scientific and data analytics communities to develop AI and machine learning (ML) models to predict cardiovascular health outcomes, including readmission and mortality. 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
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
Use of ethylene oxide (EtO) for medical device sterilization is safe for employees, neighbors and communities, and is the only viable method for many of the 20 billion devices it sterilizes each year, according to testimony given last week at the Environmental Protection Agency (EPA) public hearing on its proposal to reduce EtO from commercial sterilization facilities. 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
The nonprofit European Association of Medical Devices Notified Bodies, known as Team NB, has published a form letter for updating devicemakers on the status of their submissions as the EU continues the transition to its new Medical Device Regulations (MDR). 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
Medical devicemaker Stryker has disclosed that U.S. authorities are conducting an investigation of the company for potential violation of an antibribery law covering overseas business, making this the third such investigation of the Kalamazoo, Mich.-based company in a decade. 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
Congress granted the FDA new authority under the Food and Drug Omnibus Reform Act of 2022 to ban a medical device for one or more intended uses, but it remains to be seen how the agency will use the new enforcement tool, according to Washington, D.C.-based attorney John Claud of the law firm Hyman, Phelps & McNamara. Read More