The US Food & Drug Administration is once again proposing a mandatory summary of key labeling information be dispensed with every prescription drug. Will the idea stay on the books this time?

The US Medicaid program is proposing what amounts to a price negotiation program by using a survey/audit authority as a 'stick' to encourage manufacturers to offer supplemental rebates or outcomes-based contracts. Is it an offer sponsors can’t refuse?

The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.

CMS says it has not changed its historical policy towards drugs granted Accelerated Approval. The agency does, however, appear to be suggesting grounds for skepticism towards novel uses of the regulatory pathway.

A unanimous US FDA advisory committee vote in favor of a landmark decision to make oral contraceptives available without a prescription should be history in the making. But the desire to make history – rather than address FDA’s significant concerns with the actual application for Perrigo’s Opill – seems to have carried the day.

A unanimous US FDA advisory committee vote in favor of a landmark decision to make oral contraceptives available without a prescription should be history in the making. But the desire to make history – rather than address FDA’s significant concerns with the actual application for Perrigo’s Opill – seems to have carried the day.