The U.S. FDA granted breakthrough device designation for CT-155, a prescription digital therapeutic co-developed by Boehringer Ingelheim GmbH and Click Therapeutics Inc. to treat the negative symptoms of schizophrenia. Designed as an adjunctive to pharmaceutical therapy for schizophrenia, among the most challenging mental health conditions to treat, the PDT is one of several products in the collaboration’s pipeline.
One of the latest state laws impacting prescription drug prices is a per se unconstitutional taking, a U.S. district judge said last week, but he refused to grant a preliminary injunction to shield manufacturers from the effects of Colorado’s new law while Teva Pharmaceuticals USA Inc.’s constitutional challenge moves through the courts.
After flying high in 2022, digital therapeutics (DTx) companies crashed to Earth in 2023 and scrambled to identify a path to profitability, or at least continued viability.
Six months out from the World Health Organization ending the global health emergency brought on by the pandemic, there’s no need for the World Trade Organization to expand a five-year intellectual property (IP) waiver for vaccines to COVID-19-related drugs, devices and diagnostics.
At first glance, the U.S. FDA’s draft guidance for evidentiary expectations for 510(k) implants seems to demand more rigor on these applications, but some in industry believe that several of these elevated requirements offer little or no commensurate benefit. Geeta Pamidimukkala of the Advanced Medical Technology Association (Advamed) said the draft would seem to require that manufacturers preemptively explain the exclusion of animal testing, a requirement she said creates more work for both industry and FDA without offering a meaningful benefit.
The U.S. FDA has commenced with a pilot program for companion diagnostics (CDx) for oncology therapies, which fulfills in part a 2014 agency guidance on the use of CDx. The FDA expects to enroll only nine reference drugs and the associated companion test, but the pilot program is part of the FDA’s controversial attempt to deal with lab-developed tests (LDTs), specifically those tests that are used to determine whether a patient is likely to respond to a particular oncology treatment.
The U.S. Office of Inspector General (OIG) reported that it and Philips Respironics have come to terms over allegations that the company violated the False Claims Act (FCA) by offering free CPAP masks to operators of sleep clinics
The med-tech industry had high hopes in 2023 regarding Medicare coverage for breakthrough medical devices, but those hopes were dashed when the U.S. Centers for Medicare & Medicaid Services (CMS) withdrew the associated draft rule and will instead issue a “notice” regarding the Transitional Coverage for Emerging Technologies (TCET) concept.
In his latest effort to boost the U.S. manufacturing base, President Joe Biden is invoking the Defense Production Act (DPA) to expand the domestic production capabilities for essential medicines, medical countermeasures (MCMs) and their critical inputs.
As calendar year 2023 limps to the finish line, a number of important regulatory developments emerged and then submerged, but one development that is also a non-development took center stage in the world of med tech. The U.S. FDA has proposed a regulation for lab-developed tests (LDTs), an issue that has been simmering for the better part of a decade thanks in no small part to Congress’ failure to pass legislation that would eliminate the FDA’s controversial approach to rulemaking.
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