End Of ‘Phase I’: The Case To Re-Name First-In-Human Oncology Trials
US FDA’s push to re-think oncology dosing should begin by renaming the initial human trials to de-emphasize toxicity, a National Cancer Institute official suggests.
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The Power Of The Open Public Hearing
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.
US Medicare Agency Clarifies View Of Accelerated Approval
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.
When History Has Its Eyes On You: Opill Vote Puts US FDA In Tough Spot
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.