FDA’s reconsideration of its new Risk Evaluation & Mitigation Strategy authority put the brakes on use of the new post-marketing safety tools as 2011 began, and a formal decision not to require REMS for all products with mandatory MedGuides means a significant step down in use of REMS in the future. But that doesn’t mean REMS won’t be routine in the future.
By Michael McCaughan
In January 2010, every single original new drug application cleared by the Food & Drug Administration included a Risk Evaluation...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
The FDA deputy commissioner emailed staff asking anyone interested in the position to send her their curriculum vitae, an unusual method for finding candidates for a high-level position.
Pink Sheet reporter and editors explain Tidmarsh’s abrupt resignation as the FDA’s chief drug regulator and the potential impact on the already reeling agency.
The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.
Employees subject to the April 1 reduction-in-force began noticing severance payments had been stopped the week of Nov. 3, before the FDA Office of Human Capital Management announced the suspension of all payments to former staffers due to the lapse in appropriations.
As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.
Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”
The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.
