Protection of study subjects
FDA issues a draft guidance specifying the responsibilities investigators have to protect the rights and safety of patients participating in clinical trials. FDA says the agency became increasingly aware that current guidance and regulation - codified primarily in the 1970s - did not adequately address the increasing complexity of the modern clinical enterprise, including outsourcing. Comments are due by July 9...
You may also be interested in...
Vacancies Reform Act requires individual in an acting position to step down in order to be nominated to the permanent post but there are exceptions. Andrew von Eschenbach retained acting title during his nomination in 2006.
To help with the transition to Biden’s COVID-19 response, Woodcock will retain some therapeutic development duties in the program the Trump administration had called Operation Warp Speed.
If not reversed by the Biden Administration, demo program that puts plans at increased risk in catastrophic phase would also enhance negotiating leverage for drugs in the protected classes.