The first stage of REMS implementation from March 2008 until December 2009 was relatively easy. FDA and drug sponsors leaqrned how to adapt existing communications programs and techniques to deliver new safety messages. Now both the agency and the sponsors are moving into new territory: evaluating REMS. Both are grappling with the challenge of how to show that programs are working.
Cole Werble
FDA's initial efforts to impose post-marketing controls on drug sponsors under the Food & Drug Administration Amendments Act were surprisingly...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.
The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.
The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.
