Qualification program creates a pathway to evaluate Clinical Outcome Assessments (COAs) that capture a specific concept of interest (COI) in a specified Context of Use (COU). If successfully qualified ...

After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

THE new Food and Drug Administration (FDA) application procedures are expected to reduce the drug permit process by as much as half, an official said. “With these three policies, the processes will ...

The FDA is phasing out animal testing and moving to more human-relevant methods. This was announced as one of Marty Makary’s ...

DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to ...

Animal testing requirements for monoclonal antibodies and other medications will be “reduced, refined or potentially replaced ...

The FDA made a historic decision to phase out animal testing and switch to human-relevant methods in drug testing and development. Many say animal tests are simply too costly, take too long and ...

Adam Feuerstein, a senior writer and biotech columnist, is the author of Adam’s Biotech Scorecard, a subscriber-only newsletter about the crossroads of drug development, business, Wall Street ...

On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced a series of ...

Confusion over the Food and Drug Administration ... took to social media to defend the FDA’s controversial handling of the company’s submission. In the process, Makary and a spokesman ...