FDA

CRN suggestion that FDA prioritize facility inspections on firms which haven’t been cleared in third-party audits apparently has support at agency. But FDA hasn’t been receptive to adjusting its policy on precluding from use as dietary ingredients any substance studied or approved as a drug.

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

Sponsors of generic drug applications that miss a goal date, but do not receive an action because of complex scientific or legal questions, would get a notice outlining the lingering issue as part of a new pilot program that might become permanent in the next review cycle.

Respondents to the FDA’s questions over biosimilar development did not hold back. So, what is it: product-specific or product class-specific guidance? Or nothing?

Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”

In first of two articles from recent interview, president and CEO Steve Mister discusses examples the trade group provides for self-regulation, “where people or companies who might not do it on their own because it would put them at a disadvantage if they were the only ones.”

Supreme Court’s Loper Bright “decision is central to this case,” says Jonathan Emord, attorney representing Alliance for Natural Health USA and Meditrend Inc. in a complaint filed in US District Court for the District of Columbia.

California authorities say predominance of retailers licensed to sell hemp are compliant with ban published effective on 3 October through emergency regulation. But hemp industry’s contesting the regulation in state court, arguing state authorities inappropriately used emergency action to change state law on hemp products legislature passed in 2021.

Medtech Insight was on the ground at HLTH looking for innovative companies. Learn about seven start-ups using AI to help physicians detect conditions including prostate and breast cancers, seizures and heart failure; assess patients for cognitive decline validate and deploy algorithms, and monitor patients in and out of the hospital.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.