US FDA commissioner nominee suggests breakthrough concepts should be more widely adopted within the review divisions and that staff should find and distribute best practices.
Scott Gottlieb expects ideas for creating more consistency within FDA's review divisions, particularly in embracing the breakthrough therapies program, would come from his own staff.
During an April 5 Senate Health, Education, Labor and Pensions Committee hearing on his confirmation as FDA Commissioner, Gottlieb promoted a "bottom-up approach" to improving the performance of the review...
The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.
The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.
The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.
The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.
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.
