A team from the University of California, San Francisco, created a new electroporation-based CRISPR-Cas9 method, which eliminates viruses from the gene editing process and lays the groundwork for “safer, more precise and more efficient editing for CAR-T cancer...
On July 11, 2018 the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) offered 6 new draft guidance documents on human gene therapies. The documents offer a look at what it expects from an industry that is becoming very popular,...
The Department of Health and Human Services (DHHS) and other federal departments and agencies announced that there will be an additional six-month delay in the general compliance date for changes made to the Federal Policy for the Protection of Human Subjects,...
FDA Commissioner Scott Gottlieb, M.D., released a statement on June 12, 2018 discussing new agency efforts. Throughout the statement, Gottlieb acknowledges how biological advancements have led to the development and FDA approval of targeted treatments for patients...
On May 22nd, the House voted to approve a version of “right-to-try” legislation. The bill passed by a vote of 250-169. The bill is intended to help patients with life-threatening conditions, allowing them to access medicines that the Food and Drug Administration (FDA)...
Institutional review boards were established to protect the rights and welfare of human research subjects. Review and approval by an IRB are necessary before human subject research can begin. Last week, the US Food and Drug Administration (FDA) and the Department of...
