US FDA commissioner nominee could face a slew of questions about non-drug issues such as e-cigarette regulation, which may mean pharma must read between the lines for insight into his drug-related policy stances.
Stakeholders may be mining US FDA Commissioner nominee Stephen Hahn's answers to questions about e-cigarettes and other non-pharma issues for clues about his drug policy stances.
Hahn almost surely will be asked some questions about drug development and approval during his 20 November confirmation hearing. However, several unrelated issues are dominating the headlines and may influence...
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
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 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.
