When Robert Califf became the new commissioner of the U.S. Food & Drug Administration, he did so with a plan to emphasize the use of real-world evidence (RWE) in Agency decisions. So, even though the FDA has been evaluating the use of RWE and issued draft guidance a few months ago, “There’s still quite a bit to do,”…
As the US Food and Drug Administration’s patient-focused drug development initiative hits the 10-year mark, stakeholders are eyeing ways the program has evolved and additional changes they would like to see. Primary responsibility for organizing and leading PFDD meetings in specific disease areas has shifted from the FDA to patient advocacy groups, and participants are…
Friends of Cancer Research (FOCR) has issued a white paper calling on the U.S. Food and Drug Administration (FDA) to exercise greater regulatory flexibility in the validation of rare biomarker diagnostics and to streamline and expedite the review of companion diagnostics that target rare biomarkers or indications. The white paper, which was developed without input from…
Lawmakers behind a bill to revamp diagnostics regulation are eyeing FDA user fee legislation as a vehicle for pushing their proposal across the finish line. “The time for Congress to clarify the rules of the road for diagnostic testing is now,” Rep. Larry Bucshon (R-Ind.) said yesterday during a Friends of Cancer Research event. He and Rep. Diana…
Emerging bipartisan resistance to President Joe Biden’s idea of a multibillion-dollar science agency shows lawmakers are increasingly divided about funding medical research, in the wake of the coronavirus pandemic. “Every American agrees we must lead the world in scientific research,” a Republican leadership aide, who is close to the discussions, told Politico. “But, based on member…
Lawmakers behind a bill to revamp diagnostics regulation are eyeing FDA user fee legislation as a vehicle for pushing their proposal across the finish line. “The time for Congress to clarify the rules of the road for diagnostic testing is now,” Rep. Larry Bucshon (R-Ind.) said Tuesday during a Friends of Cancer Research event. He…
Bipartisan support for one of President Joe Biden’s pet health projects is crumbling as Republicans home in on spending and Democrats split over its structure. Emerging resistance to Biden’s idea of a multibillion-dollar new agency to tackle some of health care’s biggest challenges reflects a widening gap over what used to be a cross-party island…
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 learn that FDA is convening its external expert group on medical device GMPs to discuss its plan to…
President Joe Biden’s decision to appoint two people to temporarily fill the White House’s top science advice position—a job typically held by one appointee—is drawing mixed reactions from the U.S. research community, including opposing takes from two former presidential science advisers. The Biden administration said yesterday it is “doubling down on science” by appointing geneticist Francis Collins,…
The White House decision to tap Francis S. Collins as the president’s acting science adviser signals the administration’s priorities in advancing biomedical research and gives the recently retired NIH chief more influence to pick his successor. Biden announced two appointments to fill the roles held by Eric Lander, who resigned this month as science adviser and director of the…
