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In the News

May 21, 2019
Executive Summary While the US FDA works to cut time necessary to approve expanded access applications, sponsors are creating delays by mandating patients and institutions sign contracts to gain... Read more
May 20, 2019
Although study findings have identified tumor mutational burden (TMB) as an important factor in responses to cancer therapy, establishing a definition for expression of this biomarker and harmonizing... Read more
May 20, 2019
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 ther... Read more
May 20, 2019
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... Read more
May 17, 2019
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... Read more
May 15, 2019
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... Read more
May 14, 2019
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... Read more
May 14, 2019
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... Read more
May 13, 2019
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... Read more
May 9, 2019
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... Read more