Legislation

The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.

“I think the Republican Congress is going to slow down all of what's called progress, for lack of a better word, toward having hemp be accessible to folks in all kinds of forms,” says Doug Gansler, former Maryland state AG and chair of Cadwalader, Wickersham & Taft LLP’s state AG practice.

Questions from researchers and public health advocates during workshop to discuss FDA authority under PREA Act point to agency and OTC NDA sponsors having additional boxes to check on potential unmet needs in drugs indicated for children and specifically on clarity of labeling for consumers of low health literacy, narrowing indications to prevent confusion and education about OTC drug formulations for health care providers.

President-elect Trump’s nomination of Robert F. Kennedy Jr. as HHS secretary could be a focal point of change for FDA’s approach to Congress.

France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.

“MoCRA confirms in many ways FDA’s adherence to a risk-based cosmetics regulatory framework, and in that way, it’s very positive,” says Francine Lamoriello, global strategies executive vice president at the Personal Care Products Council.

Companies are being encouraged to look at whether they will be impacted by new UK rules on supplementary protection certificates that come into effect from the beginning of next year.

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.