May 15, 2025
September 16, 2024
June 17, 2025
February 10, 2026
The public qualification pathway created in the 21st Century Cures Act has “not lived up to its billing,” but draft commitment letter language could help to address funding, expertise and incentive shortfalls. Key Takeaways The FDA biomarker qualification program established in the 21st Century Cures law is under-utilized and under-resourced. The FDA and industry agreed…
Read MoreFebruary 9, 2026
A meeting hosted by Friends of Cancer Research put a spotlight on the rising potential of circulating tumor DNA and AI-enabled tumor assessment in cancer drug development. An FDA program designed to validate biomarkers for regulatory use may be ill-suited to quickly advance these tools and others like them, however. Background on biomarker development Biomarkers…
Read MoreFebruary 5, 2026
An FDA program that seeks to expedite drug reviews for companies in line with the Trump administration’s priorities should focus on efficiency in evaluations, not speed, the agency’s former drughead said Thursday. “This voucher program has an emphasis on speed, which I think is a very sophomoric aim at aspiration,” said Richard Pazdur, who briefly…
Read MoreJanuary 6, 2026
The nonprofit Friends of Cancer Research (Friends) held its annual meeting exploring innovative ways to streamline clinical trials safely to bring effective therapies to patients earlier. Friends has strongly supported faster approval of effective cancer drugs, including the Breakthrough Therapy designation at the U.S. FDA. The annual meeting was held during the government shutdown. Friends…
Read MoreDecember 19, 2025
The agency’s high-level turnover and conflicting policy decisions on drug oversight have fueled concerns about the leadership of Dr. Marty Makary. Days after a division chief at the Food and Drug Administration resigned amid accusations that he used his federal power to seek revenge on a former business associate, the scandal took on a new…
Read MoreDecember 15, 2025
A Friends of Cancer Research working group believes “seamless” trial designs could be used more frequently for rare cancer drug development, but advanced planning is key. Key Takeaways A Friends of Cancer Research working group argued “seamless” clinical trials could be used more often in rare cancer treatment development. Lola Fashoyin-Aje said the design requires…
Read MoreDecember 4, 2025
The Food and Drug Administration plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, FDA Commissioner Marty Makary told STAT on Wednesday. While historically the FDA has required two trials for added assurance of a drug’s safety and efficacy, it has become increasingly flexible and many drugmakers…
Read MoreDecember 2, 2025
Not a subscriber? Sign up here to get this newsletter in your inbox. FDA shockwave: Richard Pazdur’s retirement announcement jolts Washington and renews concerns about leadership churn inside an already turbulent FDA. Vaccine panel preview: The Washington Post spoke with incoming ACIP chair Kirk Milhoan about plans for the panel’s upcoming meeting and concerns from public health experts…
Read MoreDecember 2, 2025
Richard Pazdur had clashed with Trump officials on the legality and pace of their initiatives. His sudden retirement adds to the recent upheaval at FDA. The nation’s top drug regulator, Richard Pazdur, has decided to retire three weeks after taking the job. Pazdur privately mused last month about retiring from the Food and Drug Administration or…
Read MoreDecember 2, 2025
Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position. Key Takeaways Richard Pazdur, the FDA’s longtime oncology leader, is planning to leave the agency at the end of December, about one-and-a-half months after he…
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