Features

HHS Delays Common Rule Another Six Months and Adopts Three Exceptions

June 25, 2018

In a widely expected move, HHS issued a final rule to once again delay implementation of the revised Common Rule on the protection of human subjects in clinical trials until Jan. 21, 2019, and to permit an exception from the existing federal policy for three burden-reducing provisions during the delay period.

FDA Plans to Reorganize CDER around Multi-disciplinary Teams and to Streamline Reviews of New Drug Applications

June 11, 2018

A new reorganization at the FDA’s Center for Drug Evaluation and Research will assign multidisciplinary teams to work on new drug applications from the beginning of the regulatory process, will centralize project management under the Office of New Drugs, and increase the number of offices overseeing review divisions from five to nine and increasing the overall number of review divisions from 19 to 30, the agency announced June 4.