“The FDA process is time-consuming and costly. There’s no reason to do it if your product is not going to cross the line," said Ariel Seeley, a Morgan, Lewis & Bockius partner. The explosion in recent ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
But their efforts have fallen far short of solving the problem. Congress’ first attempt to address the problem was the creation of the de novo process itself in 1997. Unfortunately, as explained above ...
On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
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 ...
The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal worker ...
Forbes contributors publish independent expert analyses and insights. Tor Constantino is an ex-reporter, turned AI consultant & tech writer. In a landmark for U.S. public health digital transformation ...
On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results