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Category: In the News

Medical Device and Diagnostics Industry — Outgoing FDA Commissioner Responds to Possible Changes by Trump Administration

At a Glance Califf emphasized that the agency is focused on its work, despite uncertainty about the incoming administration’s changes. Robert F. Kennedy Jr. criticized the FDA’s nutrition division, but Califf chose not to engage with his remarks. Califf acknowledged that the new administration is expected to implement significant reforms. Earlier this month, Robert F.…

Inside Health Policy — Trump’s Planned Ramaswamy-Musk Commission Stokes Fears Of Major FDA Cuts

President-elect Donald Trump has announced that biotechnology executive and FDA critic Vivek Ramaswamy, along with controversial businessman Elon Musk, will head a new commission to slash federal regulations and slim down federal government spending, raising further concerns about potential rollbacks of rules and major staff cuts at FDA and other health agencies. Ramaswamy said the…

PoliticoPro — Califf: ‘We just don’t know what’s going to happen’ at FDA

FDA Commissioner Robert Califf said Tuesday he’s “disappointed” in the presidential election results and acknowledged the uncertainty President-elect Donald Trump’s return to the White House raises for the agency workforce. “We just don’t know what’s going to happen now,” he said during the Friends of Cancer Research annual meeting. ”It’s not correct of me to…

Pink Sheet — Industry Support Key To US FDA’s Prospects Under Trump – Califf

How the US Food and Drug Administration fares during President-elect Donald Trump’s second term will depend, in part, on industry’s support for the agency and its staff, Commissioner Robert Califf told the Friends of Cancer Research annual meeting on 12 November. Califf’s second term as commissioner will end when Trump takes office in January. “This…

Stat+ — FDA commissioner suggests RFK Jr. and Trump might compromise an agency ‘at peak performance’

WASHINGTON — Food and Drug Administration Commissioner Robert Califf said he’s unsure about the future of the agency under the incoming Trump administration and “disappointed” about the election’s outcome. “I think we just don’t know what’s going to happen,” Califf said at a conference hosted by the nonprofit Friends of Cancer Research on Tuesday. “The gist of…

Regulatory Focus — Califf ‘disappointed’ about election, warns of changes at FDA

Robert Califf, commissioner of the US Food and Drug Administration (FDA), said he is “disappointed” in the outcome of the presidential election and warned of potential changes coming to the agency under a second Trump administration. Califf delivered these remarks during the Friends of Cancer Research (FOCR) annual meeting in Washington, DC on Tuesday, where…

Endpoints News — ‘Expertise is a real thing’: FDA commissioner warns of political risk to agency

With just a few months to go before he likely steps down, President Biden’s FDA Commissioner Rob Califf weighed in on how the agency might be affected by the incoming administration. Califf, while not mentioning President-elect Donald Trump by name, or his healthcare lead, Robert F. Kennedy Jr., made pointed remarks on Tuesday about the…

Bloomberg Law — FDA’s Califf Braces Agency for Staff Changes After Trump Victory

The FDA is standing by for changes within the agency after Donald Trump’s victory in the 2024 presidential election, agency Commissioner Robert Califf said Tuesday. “Change can happen internally or externally,” Califf said. “We have to wait and see and have some faith that hard-working, high-quality people are going to still be in place and…

BioCentury — Turning ctDNA into an intermediate endpoint will require harmonization

Friends of Cancer Research annual meeting to discuss validation of ctDNA endpoints, plus interim OS analysis and pragmatic trials Evidence for circulating tumor DNA reduction as a new intermediate endpoint to support accelerated approvals of solid tumor therapies is nearing a tipping point. The endpoint stands to transform clinical development across many settings, but it must first…

Inside Health Policy — Public Citizen Lays Out Legal Arguments For FDA Keeping LDT Role

As election results approach and speculation mounts amid concerns that Donald Trump if elected to a second term would once again ax FDA’s oversight of lab-developed tests (LDTs), Public Citizen, joined by five other organizations, submitted an amicus curiae brief Monday (Nov. 4) laying out legal arguments for why FDA should continue to regulate LDTs as medical…