FDA Orphan Drug Reviewers Should Seek Help From NIH, Genzyme Says
CEO Meeker suggests a program where NIH scientists have a rotation at FDA where they take part in drug reviews for an extended period, instead of only for a short time as a consultant.
You may also be interested in...
FDA needs to formalize the flexibility it has employed in its rare disease program, according to Tim Coté, the National Organization for Rare Disorders’ new Chief Medical Officer and former head of the agency’s orphan products development program.
Pink Sheet Podcast: Another Coronavirus Stimulus Bill, Remdesivir’s Brief Orphan Status, Teva Sues Over Copaxone Regulation
Pink Sheet editor and reporters discuss the effects of the latest coronavirus stimulus package on pharma, Gilead’s request for rescission of an orphan designation, and Teva’s suit over Copaxone regulation.
What's in – and what fell out of – the massive US stimulus package.