PMA USER FEES COULD PROVIDE "FIX" NOT IN FDA REFORM PROPOSALS, KESSLER SUGGESTS; FDA COMMISSIONER REITERATES OPPOSITION TO THIRD-PARTY PMA REVIEW
This article was originally published in The Gray Sheet
Executive SummaryCharging user fees for FDA review of premarket approval applications as an alternative to current legislative reform proposals was suggested by agency Commissioner David Kessler May 6 at the inaugural meeting of the Massachusetts Medical Device Industry Council (MassMEDIC) in Boston.
You may also be interested in...
A collaboration between Novo and Fauna will look at animal hibernation and genetic sequencing for hints toward novel therapies for obesity. Pfizer will use Insilico’s machine learning technology in target validation.
The introduction of gene therapies has been the highest-profile new modality to reach the market, but new RNA-based therapeutics hold significant potential and could be more accessible for patients. Scrip reviews the leading drug developers in this space.