Category: In the News

Two in­flu­en­tial non­prof­its fo­cused on can­cer drug R&D are urg­ing the FDA to take a more flex­i­ble ap­proach to clin­i­cal work to help triage an in­flux of new cell and gene can­cer ther­a­pies mak­ing their way to hu­man stud­ies. By chang­ing cur­rent IND and man­u­fac­tur­ing stan­dards, they say, the agency can cut the time and…

A new white paper from the Friends of Cancer Research (FOCR) and the Parker Institute for Cancer Immunotherapy calls on the US Food and Drug Administration (FDA) to ease clinical and manufacturing requirements to speed early development of anti-cancer cell therapies. In recent years cell therapies, including engineered T-cell receptor (TCR) and chimeric antigen receptor…

A risk-averse culture at universities and cancer centers holds back a field of potentially life-saving cell transplantation therapies, scientists said.   “Patients are waiting. These therapies are curative. They’re important for the field,” Ellen V. Sigal, chairperson and founder of Friends of Cancer Research, said during a May 17 meeting on the future of cell…

NIH concerns slammed the brakes on a bill May 15 seeking more transparency about people serving on federal advisory boards.   The Senate Homeland Security and Governmental Affairs Committee agreed to postpone voting on the Federal Advisory Committee Act (H.R. 1608) to address any negative impact on medical research.   The National Institutes of Health…

The US National Institutes of Health opposes a bill wending its way through Congress aimed at making government advisory committees more transparent, Science reports.   At hand, it says, is the 1972 Federal Advisory Committee Act, which sets rules for how committee members are chosen and how meetings are run. But, it says there have…

As Congress considers comprehensive reforms to the regulatory paradigm for all in vitro clinical tests (IVCTs), including LDTs, recent developments are highlighting the limitations of FDA’s current posture of enforcement discretion.   First, FDA is sufficiently concerned about certain types of LDTs that might lack clinical evidence supporting their claims that the agency issued a…

The much-admired system to review grant proposals at the National Institutes of Health (NIH) in Bethesda, Maryland, has become the latest flashpoint in a long-running battle between Congress and the executive branch over how the U.S. government manages advisory bodies.   NIH’s parent body, the Department of Health and Human Services (HHS) in Washington, D.C.,…

Executive Summary Acting commissioner is entering the usual learning curve for new leaders of the agency. It’s a reminder of how unusual it was to skip that step under his predecessor.   After one month on the job, acting US FDA Commissioner Ned Sharpless is starting to take on a higher public profile.   On…

Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests. The groups have different views on FDA’s purview, but they generally agree…

At a Friday meeting FDA co-hosted with ASCO and Friends of Cancer Research, patient advocates expressed concern over their ability to access newly approved tissue-agnostic medicines, as well as clinical trials assessing up-and-coming treatments based on molecular markers rather than tissue of origin. Stakeholders also raised concerns about the lack of access to tumor-profiling technologies…