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 Consumer Health Industry In 2023: With Supply Chain Concerns Constant, Challenges Loom Larger
OTC drug and dietary supplement industry trade group executives discuss questions on potential market and regulatory developments affecting their members’ businesses. HBW Insight begins reporting from those talks with outlook for supply chain nd production disruptions and prevalence of COVID-19 and other widespread viruses.
To Prevent Shortages, US FDA Wants Notices From Drug Firms On Spikes In Demand
Demand-related shortages are a relatively new problem, but FDA maintains its tools can prevent or end them.
US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close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.