The World Trade Organization wrapped up its 13th ministerial conference and, as the saying goes, no news is good news. Life science trade associations in the U.S. lauded the end of the conference without an extension of intellectual property rights waivers for therapies and diagnostics for the COVID-19 pandemic, although this outcome was not entirely surprising.
The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.
Legislation passed in the U.S. Congress in 2013 called upon the federal government to dispense with the Federal Helium Reserve by September 2021, a deadline that some stakeholders are grateful to see has passed without action.
Sometimes a small change of wording has a big effect on the implications of a U.S. FDA guidance, a notion that may apply to the U.S. FDA’s final guidance for the use of computational modeling in device premarket submissions.
The U.S. Environmental Protection Agency (EPA) has struggled to devise a final rule regarding regulation of ethylene oxide (EtO) after several years, a regulatory activity that has device makers concerned about domestic capacity for sterilization.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCPs) is one of the more innovative regulatory proposals in recent memory, although the FDA is not statutorily required to limit this policy to artificial intelligence (AI) and machine learning (ML) products. Nonetheless, the PCCP concept is starting to show signs of being consumed by the debate over AI and ML medical software, so much so that industry may be losing sight of the opportunities the PCCP concept offers in other types of medical technologies.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was a long time in coming, much longer than any legislative proposals to overhaul the agency’s regulatory mechanisms for these tests. Nonetheless, Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed), believes that the FDA draft rule is likely to prompt Congress to pass the Verifying Accurate, Leading-edge IVCT development (VALID) Act, a development that would truncate an FDA final rule that would almost certainly face litigation.
The U.S. Centers for Medicare & Medicaid Services is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.
The U.S. Centers for Medicare & Medicaid Services (CMS) is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.
The question of third-party litigation funding has been front and center for life science companies in recent years, with one of the key considerations a lack of transparency as to the source of the funding behind much of this litigation. That lack of transparency was front and center in the Sept. 13 hearing in the U.S. House of Representatives, but the tenor of the hearing made clear that some members of Congress will stand in opposition to any reforms even though the lack of transparency is widely seen as enabling meritless litigation.