Jean Hurley3 min read
GRIP2 min read
Jean Hurley4 min read
As healthcare undergoes one of its most volatile chapters in recent memory, some major developments signal a deeper reckoning with how America manages its medicines,…
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
The FDA noted how foreign companies have been given advanced notice before facility inspections, while American manufacturers have not.
Julie DiMauro2 min read
At the annual pharmaceutical compliance event, speakers discussed the Gilead False Claims Case and Trump administration initiatives.
Julie DiMauro5 min read
Updates on US pharmaceutical policy, compliance, and regulation.
Vlada Gurvich5 min read