“Bad idea.”
That is how Amgen SVP-Global Regulatory Affairs & Safety Steven Galson characterized the Trump Administration proposal to increase user fees to cover the full cost of product reviews. Galson, the...
The Trump Administration isn’t likely to drop the idea of having user fees pay the full cost of reviews. The pharmaceutical industry can afford higher fees, but industry officials worry about the perception if reviews are fully funded.
“Bad idea.”
That is how Amgen SVP-Global Regulatory Affairs & Safety Steven Galson characterized the Trump Administration proposal to increase user fees to cover the full cost of product reviews. Galson, the...
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.