“The development of psychedelic medicines should adhere to the current European regulatory framework, at both the pan-European and member state level. It is imperative that developers understand and thoroughly apply the regulatory guidance and requirements that are in place.” That was the somewhat discouraging opening statement at the stakeholder workshop convened by the EMA to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health.
The U.S. FDA’s December 2023 draft guidance for the use of real-world evidence (RWE) for medical devices drew comment from across the spectrum of stakeholders, but industry is demonstrably wary of the draft on several points. The Medical Device Manufacturers Association (MDMA) offered several pointed criticisms, including that the draft seems to suggest that a fit-for-purpose study might be nearly indistinguishable from a conventional clinical trial, which MDMA said violates the least burdensome principle.
The U.S. Medicare program for coverage of U.S. FDA-designated breakthrough devices has gone through some significant alterations over the past few years, but there is legislation on Capitol Hill that would codify this program at the Centers for Medicare & Medicaid Services. Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), told BioWorld that one of the sources of drag on this kind of legislation is how the Congressional Budget Office (CBO) scores the legislation, a problem that might not be resolved until CBO works through other legislation.
Following the decision of Australia’s Therapeutic Drugs Administration to allow prescribing of MDMA for post-traumatic stress disorder and psilocybin in treatment-resistant depression from July 2023, and with U.S. FDA approval of MDMA for treating PTSD expected in 2024, the EMA is under increasing pressure to set out a path to approval for psychedelics.
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. 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 proposed U.S. Medicare framework titled Transitional Coverage for Emerging Technologies (TCET) promises to expand on existing mechanisms for Medicare device coverage, but industry has serious misgivings about the proposal.
The U.S. Centers for Medicare & Medicaid Services (CMS) finalized the Medicare inpatient prospective payment system for fiscal year 2024 with a number of new and renewed new technology add-on payments (NTAPs) for the coming fiscal year. Controversially, however, the agency retained a proposal from the draft that requires that a product have received market authorization from the FDA by no later than May 1 of the prior fiscal year to qualify for NTAP payment, a provision that industry has blasted as exclusionary of products that merit an NTAP payment.
The U.S. FDA’s draft guidance for predetermined change control plans (PCCP) is a groundbreaking document for med-tech regulation, but stakeholders see a few holes in the draft version. One of the issues for device manufacturers is that the guidance seems to exclude any possibility of inclusion of a new intended use or indication for use in a PCCP, while others seek more detail on how this policy can be applied to the device component of a combination product, two elements that may prove complicated to address in the final guidance.