US FDA Needs ‘More Clout’ To Get Supply Chain Information, Califf Says
‘It’s driving me crazy that supply chains are a trade secret,’ FDA commissioner states. Agency also needs more clout to handle accelerated approvals, he tells gathering of industry executives and government policy makers.
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US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close
Fourteen of 15 advisory committee members said the preterm birth prevention drug should come off the market while a new study is conducted; panelists cited concerns about allowing continued marketing when efficacy has not been demonstrated, and they rejected Covis’ assertion that it would be harder to recruit a new study if Makena were pulled.
‘Industry Failing On Evidence Generation,’ US FDA’s Califf Says Of Accelerated Approvals
As a “laborious” hearing at the Food & Drug Administration on whether to withdraw the accelerated approval for Covis’s pre-term delivery drug Makena, FDA chief Robert Califf commented that industry is not doing enough to provide the evidence required for the fast-track approval pathway.
After ‘Clean’ User Fee Renewal, Will Programs Held Hostage Be Enough To Drive A Broader Reform Bill?
Continuing resolution will force lawmakers back to the bargaining table before year end. Orphan grants and pediatric exclusivity are among the programs left out of the short-term spending measure as Congressional Democrats seek leverage to add more policy riders.