Legislation

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.

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.

With a looming deadline of 1 January 2025 for firms supplying Northern Ireland to comply with the Windsor Framework, UK generics and biosimilars association the BGMA has warned of potential supply interruptions due to requirements that include a “UK only” label for all packs as well as UK-based batch testing for biologicals.

Olivér Várhelyi’s plans for his new role boil down to continuing legislative projects and other initiatives that have already been set in motion.

French industry association Gemme has issued a stark warning that recent legislative proposals – including a revision to the country’s clawback mechanism and steeper financial penalties for failing to hold sufficient safety stocks – will “bring about the end of the generic economic model in France.”

The EU Clinical Trials Regulation has “so far failed to improve Europe’s competitiveness,” according to a new report commissioned by the pharmaceutical industry body EFPIA.

A ruling by the Court of Justice of the EU has produced a clear definition of what constitutes the “first” marketing authorization when companies apply for SPCs on pharmaceutical products.

Sponsors can expect to see a copy of final guidance on how to comply with the UK’s new clinical trials regulation in August 2025, while the new framework is set to apply from January 2026.

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.