Layoffs and other staff reductions at the US Food and Drug Administration are a “slow-moving catastrophe” that will undermine drug approvals in subtle ways, former Principal Deputy Commissioner Janet Woodcock said. The “whole apparatus to get a drug on the market has been undermined,” Woodcock said 7 April at the Biopharma Congress, presented by Prevision…
As President Donald Trump’s massive overhaul of federal agencies continues, several former FDA officials spoke about the potential ramifications for drug reviews and provided a look inside current FDA conditions. “Leadership in the agency’s been decapitated, and I think that was somewhat deliberate,” Janet Woodcock, M.D., former acting FDA commissioner and former principal deputy commissioner of…
A federal judge in Texas quashed the Food and Drug Administration’s plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds. “The Court VACATES and SETS ASIDE, in its entirety, the FDA’s Final Rule titled Medical Devices; Laboratory Developed Tests,” the ruling reads.…
The Food and Drug Administration’s top vaccine official, Dr. Peter Marks, resigned under pressure Friday and said that Health Secretary Robert F. Kennedy Jr.’s aggressive stance on vaccines was irresponsible and posed a danger to the public. “It has become clear that truth and transparency are not desired by the secretary, but rather he wishes…
When newly confirmed US Food and Drug Administration Commissioner Martin Makary enters the halls of a newly-crowded White Oak on 27 March, all eyes will be watching for whether he leans in to the Trump Administration’s actions that destabilized the agency or changes course to reinvigorate morale. The Senate voted 56-44 on 25 March to…
Stakeholders want the US Food and Drug Administration (FDA) to consolidate its accelerated approval guidances. They also asked for clarification about when the agency considers a confirmatory trial to be underway and acceptable trial benchmarks. In January, FDA proposed a guidance that would hold sponsors of drugs with accelerated approval more accountable for conducting confirmatory…
For medical oncologists, the clinical quandary in treating patients is whether a newly marketed agent or drug cocktail will work as well as it did for the average cancer patient in a landmark clinical trial. “To be completely honest, I am usually just referring to the results of the trial to make my decision and…
Representatives from leading pharmaceutical firms said at a conference last week that they see minimal, or molecular, residual disease testing as the “next big game changer” in precision medicine development, and hopefully in the clinic, though they continue to grapple with how to build that bridge. Discussing MRD with technology developers and clinicians at Cambridge…
The 2025 APCCC Diagnostics annual meeting featured a session on how to monitor metastatic prostate cancer and a presentation by Dr. Alexander Wyatt discussing when we should assess biology with ctDNA. Cell free DNA (cfDNA) is from apoptosing cells shedding cfDNA into the blood, with most normal cfDNA being from the blood lineage. The average…
Harnessing Absolute ctDNA Measurements for Early Detection of Cancer Progression Recent studies indicate that measuring the absolute concentration of circulating tumor DNA (ctDNA) in patients with metastatic cancer can serve as a crucial predictive biomarker for imminent disease progression, paving the way for more timely clinical interventions. A breakthrough in metastatic cancer management has emerged…
