US Food and Drug Administration regulatory reviewer disagreements and postmarket safety actions among new therapeutics.

Ashley L EadieAndrea MacGregorJoshua WallachJoseph R RossMatthew Herder

Published in: BMJ evidence-based medicine (2023)

This investigation of regulatory reviewer disagreements and postmarket safety actions among new therapeutics suggests that disagreements among regulatory reviewers may lead to important pre-emptive actions, potentially mitigating the need for postmarket safety actions to be taken.

Keyphrases

transcription factor
drug administration
small molecule
risk assessment
human health