FDA

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework.

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

The US FDA has released its annual list of planned guidance documents for the upcoming fiscal year. While many topics on the list are familiar, a new “Under Construction” list shows rising priorities.

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

The Swiss company is aiming to regain its innovator status and expand its offering across all breast cancer settings. Approval of Itovebi is just the start.

Tricuspid valve innovation has taken off since the US FDA’s 2023 authorizations of Edwards' Evoque and Abbott's TriClip systems. Whether to repair or replace tricuspid valves remains an open, nuanced question among cardiologists. Dr. Henrik Treede of University Hospital Mainz and TriCares CEO Ahmed Elmouelhi offer views on the evolving space.

FDA grants de novo authorization to Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first OTC flu test to be cleared outside the emergency use pathway.

Manufacturers looking to change their device sterilization method as part of the move away from ethylene oxide (EtO) may be able to make use of the Predetermined Change Control Plan (PCCP) process, FDA officials said in a webinar this week.

Richard Lowenthal, co-founder and CEO of ARS Pharmaceuticals, highlights the crucial unmet need for needle-free devices to treat type 1 allergic reactions, given challenges associated with current epinephrine injectors. Hear what’s next for the Neffy intranasal spray and ARS Pharmaceuticals.