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'All Options On The Table,' Says Hillebrenner On Diagnostics Reform

 
• By Brian Bossetta

During a recent webinar hosted by the Alliance for a Stronger FDA, Elizabeth Hillebrenner, associate director for scientific and regulatory programs at the agency’s device center, vowed to keep fighting for diagnostic reform despite Congress failing to pass the VALID Act last year.

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• Source: Shutterstock

The countdown to Europe’s Unified Patent Court Agreement entry into force on 1 June has started, following Germany’s ratification of the UPCA on 17 February.

The move by the German government marked the completion of the necessary ratification procedures by the participating EU member states for the Unitary Patent Package (UPP) to become effective for 17 member states, said the European Patent Office, which has been entrusted with the administration of unitary

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More from Regulation

More from Policy & Regulation

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 
• By Brian Bossetta

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.