Policy

The Life Sciences Innovative Manufacturing Fund, set out in the UK budget last month, is live for applications. More UK medtechs would benefit if the cost threshold were scaled down, the industry argues.

The European Medicines Agency is conducting a public consultation on proposed revisions to its policy on how it handles any conflicts of interest of its scientific committee members and experts.

European cross-country HTA collaborations have much to learn from each other to keep prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.

The European Commission has now adopted the third implementing act for the Health Technology Assessment Regulation. This sets out rules for managing conflicts of interest of anyone involved in joint clinical assessments or joint scientific consultations under the regulation.

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.

European cross-country HTA collaborations have much to learn from each other to keep drug prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.

Findings of Germany’s latest annual survey of medtech opinion and business confidence are a wake-up call for European industry and heap further criticism on the EU MDR.

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.”

FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.

Biden’s order for proposed rules could boost support for Democrat Kamla Harris from undecided voters concerned about reproductive rights or for Republican Donald Trump from those who agree with his conservative stance on access to birth control, which he argues should be up to states to regulate. Proposed rules also could stir consumers not planning to vote to go to the polls.