The U.S. FDA has been working for some time to develop less clunky regulatory mechanisms for digital health products, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health, has been touting a voluntary alternative pathway (VAP) as a modernized approach to premarket review.
The Advanced Medical Technology Association (Advamed) and the Biotechnology Innovation Organization (BIO) have teamed up on a friend-of-the-court brief for the U.S. Supreme Court’s upcoming hearing on twin cases that examine the question of a defendant’s state of mind when filing claims with federal health programs. Advamed and BIO argue that the existing judicial approach is critical to ensuring that companies in the life sciences are not subject to treble damages when acting reasonably in connection with products reimbursed by federal health programs, adding that an overturn of existing judicial practice would stifle innovation at the cost of patient access to life-saving medical therapies.
To help drug manufacturers comply with the technical requirements of RCD 753/2022 and other related standards regarding proof of a drug’s safety and efficacy, Brazil’s Anvisa issued three new guidelines for submitting registration requests for new or innovative synthetic and semi-synthetic drugs.
The U.S. NIH once again faces questions about its oversight of certain research. In the latest round, the U.S. Government Accountability Office called on the agency to do more to ensure that foreign facilities conducting NIH-funded animal research are compliant with U.S. standards and policy regarding animal care and use, as well as international standards.
The U.S. Centers for Medicare & Medicaid Services (CMS) has scaled back the list of Medicare Part B drugs facing the new inflation rebate under the Inflation Reduction Act for the first quarter of 2023.
As Seagen Inc. preps for a merger, the U.S. FDA awarded accelerated approval to the company’s big-selling Padcev (enfortumab vedotin). The approval is for a combination therapy with Merck & Co. Inc.’s Keytruda (pembrolizumab) as a first-line treatment for adults with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy.
France is tightening access to the reimbursed health care market for digital medical devices. The national Digital Healthcare Agency (ANS) reported that a standard interoperability and safety system for digital medical devices is coming into force.
Masimo Corp.’s Opioid Halo, an opioid overdose prevention and alert system, was granted de novo status by the U.S. FDA. The device detects opioid-induced respiratory depression, the primary cause of opioid deaths. The de novo authorizes the company to make Halo available over the counter and by prescription for use on individuals aged 15 and up.
More than four years after it was given the authority to do so, the FDA is requiring manufacturers of opioid painkillers dispensed in outpatient settings to make prepaid mail-back envelopes available to pharmacies and other dispensers as part of their risk evaluation and mitigation strategy (REMS).
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