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November 21, 2018
Executive Summary CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.   Asked about the US's Right to Try law, Center... Read more
November 20, 2018
Executive Summary Peter Stein is a familiar face within OND and has been working alongside CDER Director Janet Woodcock on the proposed “modernization” of OND. As a previous recruit from outside FDA... Read more
November 20, 2018
FDA plans to release guidance soon that will make it easier to get a cancer companion diagnostic approved for use with an entire class of drugs, FDA Commissioner Scott Gottlieb told BioCentury.  ... Read more
November 19, 2018
When President Donald Trump rolled out an ambitious pilot program to lower the costs of physician-administered drugs in late October, policy experts expected the same swift condemnation Congress and... Read more
November 19, 2018
Executive Summary CBER Director Peter Marks says the "half-life" for the existing six gene therapy guidances likely is two to three years due to the fast pace of scientific discovery. Genetic... Read more
November 10, 2018
In an effort to determine best practices and ensure consistent clinical interpretation of tumor mutational burden ( TMB) assessment for cancer patients, a group of diagnostic test partners conducted... Read more
November 6, 2018
Results to be Presented at the Society for Immunotherapy of Cancer’s (SITC) 33rd Annual Meeting November 6, 2018 - Washington, DC – Friends of Cancer Research (Friends) is pleased to announce that... Read more
November 5, 2018
In a group of sponsored presentations at last week's annual meeting of the Association for Molecular Pathology, Thermo Fisher Scientific product users reported on their experiences in a variety of... Read more
October 30, 2018
I am a big proponent of clinical trials. I think everyone should have access to them and any trial that they qualify for should be offered – regardless of whether or not I think they are “appropriate... Read more
October 25, 2018
Next-generation sequencing is used with increasing frequency to provide essential information about a patient’s diagnosis and treatment. In recent months, the U.S. Food and Drug Administration (FDA)... Read more