GRIP2 min read
Jean Hurley19 min listen
GRIP2 min read
Our in-brief roundup of notable stories from the last week.
GRIP2 min read
The FDA has unveiled FDA PreCheck, a two-phase program designed to speed approvals and boost regulatory certainty for US drug manufacturing projects.
Vlada Gurvich3 min read
The FDA claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.
Julie DiMauro3 min read
Significant developments in the healthcare sector are pulling at the integrity of the entire system.
Vlada Gurvich3 min read
Our in-brief roundup of notable stories from last week.
GRIP2 min read
The FDA has released Elsa, an AI tool designed to optimize the performance of FDA employees such as researchers and investigators.
Julie DiMauro1 min read
The rising cost of prescription drugs is a concern for patients, healthcare providers and policymakers, but crafting a solution without undermining industry confidence is tricky.
Julie DiMauro4 min read
The FDA said its timing to scale use of AI inside its FDA centers follows the completion of a GenAI pilot for scientific review.
Julie DiMauro2 min read