Sarah Hersey, VP of Precision Medicine at Bristol Myers Squibb, gave a balanced view of the challenges and opportunities facing precision medicine in her keynote address at the Molecular & Precision Medicine Tri-Conference in San Diego this week. After her presentation she was joined by others in the space to talk about the future for…
For those to whom the name doesn’t ring a bell, Mark spent the majority of his 35-year career working to fund and further the goals of biomedical and cancer research and policy; both on Capitol Hill as senior policy advisor to Sen. Connie Mack (R-FL), and as a principal at Liberty Partners Group, the lobbying…
Center for Biologics Evaluation and Research Director Peter Marks wants people to come work at the US Food and Drug Administration, but he also understands if they leave for industry some day. “I don’t think we should get as crazy about people moving [from] FDA to industry, the back and forth,” Marks said at the…
Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) sought to change the current regulatory scheme for clinical laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). But even though the College of American Pathologists (CAP) and nine other organizations signed a…
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that FDA has filled two leadership roles at the agency, and that it will host an upcoming…
US Food and Drug Administration Commissioner Robert Califf wants advisory committees spending more time debating drug development topics that apply to multiple products, rather than the typical product-specific events. Some top FDA career professionals championed the idea along with Califf, who endorsed it during the 13 February Prevision Policy/Friends of Cancer Research Biopharma Congress, as…
The US Food and Drug Administration now has employees working at the Centers for Medicare and Medicaid Services as part of the increased collaboration spurred by the 2022 Inflation Reduction Act. FDA Commissioner Robert Califf indicated his employees are helping CMS implement the IRA, which among its many provisions includes the controversial Medicare price negotiation…
Accelerated approval is likely to be used more extensively in the future for gene therapies that treat very rare diseases, but the slowly progressive nature of some conditions means there may be many years of uncertainty about the clinical benefits provided by the one-time treatments, the head of the US FDA’s Office of Tissues and…
US Food and Drug Administration Commissioner Robert Califf is willing to explore emergency use authorization use outside of COVID-19-like pandemic situations, but also is concerned about the drug industry’s lack of financial incentives to finish studying products given the expedited path to market. Califf was asked about the potential for EUAs in areas like non-opioid…
Abstract In the era of precision oncology, use of circulating tumor DNA (ctDNA) is emerging as a minimally invasive approach for the diagnosis and management of patients with cancer and as an enrichment tool in clinical trials. In recent years, the US Food and Drug Administration has approved multiple ctDNA-based companion diagnostic assays for the…
