The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the ...
A new guidance document finalized by the US Food and Drug Administration (FDA) proposes to make it easier for pharmaceutical marketing professionals to submit their advertisements and promotional ...
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...
The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
FDA Guidance Explains Nuances of Making Changes to Generic Drug Submissions A new draft guidance document published yesterday by the US Food and Drug Administration (FDA) aims to clarify what sponsors ...
Morning Overview on MSN
FDA to pilot real-time tracking of clinical trials to speed safety feedback
When a patient in an early-phase drug trial experiences a serious side effect today, weeks or even months can pass before ...
A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results