Stephen Hahn Takes US FDA Helm Under Cloud Of Doubt About Vaping Stance
HELP Committee ranking member Patty Murray said because of Hahn's evasive responses to questions about curbing youth e-cigarette use during committee meeeting, she would oppose his confirmation. She also said she was not convinced Hahn would uphold FDA standards.
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FDA faces unprecedented challenges responding to pandemic, needing to balance urgency, speed, safety and transparency against a fast-moving background. Hahn, who spoke at a recent medical device industry conference and will testify at a congressional hearing on 23 June, says he has focused on making decisions supported by data and science, and updating those decisions as more information became available.
Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.
CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.