Please see below for key trends and regulatory developments in clinical research. The most recent announcements appear first.
October 11, 2022
On September 26, 2022, the U.S. Food and Drug Administration (FDA) announced in the Federal Registry the newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” The goal of this guidance is to provide FDA’s perspective on the ethical considerations for including children in clinical trials.
October 7, 2022
As part of its obligations under the 21st Century Cures Act, the U.S. Food and Drug Administration (FDA) announced, on September 28, 2022, two proposed rules aimed at harmonizing, to the “extent practicable and consistent with statutory provisions,” certain sections of the agency’s regulations on human subject protections and Institutional Review Boards (IRBs) with the “Federal Policy for the Protection of Human Subjects” (revised Common Rule).
April 25, 2022
On April 8, 2022, the U.S. Food and Drug Administration (FDA) adopted and issued the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E8(R1) General Considerations for Clinical Studies. ICH E8 guidelines sets out general scientific principles for the conduct, performance, and control of clinical trials, and addresses a wide range of topics in trial design and execution. This revision is the first major revision since 1997 and marks the initial step in the ICH’s Good Clinical Practice Renovation project and will continue with the revision of E6(R2) guidelines on Good Clinical Practice (GCP).
October 8, 2021
On September 30, 2021, the U.S. Food and Drug Administration (FDA) issued new draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices. This draft guidance addresses how investigators must assess and report adverse events to ensure participant safety in drug and device studies.