During an online seminar hosted by the Alliance for a Stronger FDA, Commissioner Robert Califf discussed key issues facing the agency, including supply chains, device shortages, and the risk of another pandemic.
Well into his second stint leading the US Food and Drug Administration, Robert Califf feels the country is in “serious jeopardy” with so many key ingredients for medical products coming from China — a problem, he said, that amounts to a matter of national security.
The commissioner, who spoke at a recent event hosted by the Alliance for a Stronger FDA, pointed to supply chain issues the US experienced during the pandemic which could prove problematic,
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.
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.
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.
