SEC Activity with Fixed Income and Credit Funds
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
Medical Devices Directorate Performance Annual Report - In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides...more
The U.S. Food and Drug Administration (FDA) published a final rule creating additional recordkeeping requirements for foods listed on the Food Traceability List. The final rule was published in the Federal Register on...more
On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a...more
On September 27, 2019, FDA issued a new draft guidance on Clinical Decision Support Software, supplanting its 2017 draft guidance, Clinical and Patient Decision Support Software. ...more
On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a draft guidance that will distinguish servicing activities from...more
Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance...more
Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more
Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more
Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more
Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more