A Pivotal September For US FDA And Commissioner Califf
The month of September will be a crucial time for the US Food & Drug Administration and the legacy of its commissioner, Robert Califf. The agency will be taking several significant regulatory actions – but also crossing its fingers that legislation to assure its funding is secured.
You may also be interested in...
ALS Drugs: FDA May Adjust Development Recommendations In Real Time For Ongoing Programs
Agency’s action plan for rare neurodegenerative diseases maps out over five years, but knowledge gained can inform products currently in development; new FDA grant program looks to invest in remote use of clinical outcome assessments for amyotrophic lateral sclerosis.
Califf Previews US FDA’s Authorization Rationale For COVID Bivalent Boosters
FDA Commissioner says the new shots will skip advisory committee review after June meeting on reformulation. ‘As we know from prior experience, strain changes can be made without affecting safety.’
US FDA Exploring Furlough Possibility If User Fee Bill Not Enacted In Time
Furloughs would allow affected FDA staff to remain employed, while a layoffs would require affected workers to be rehired.