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Latest From M. Nielsen Hobbs
Commissioner Gottlieb hopes accomplish through guidance a policy change that advocates failed to get included in user fee legislation passed earlier this year.
US FDA extends its own user fee deadline; biosimilars earn a dubious milestone; and EMA unveils some contingency planning for Brexit. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet
Differences between Senate and House Committee versions of the FDA Reauthorization Act passed in May and June to approve five-year device user-fee agreements have been smoothed over by committee staff and joined together in the latest version of the act. The bill has been placed on the House's calendar in anticipation of July 12 action to debate and approve the bill. Next steps in the Senate, meanwhile, remain to be seen.
'Clean' bill includes expanded access language from Senate, generic review revisions from House as legislators hope for enactment this month.
US FDA would need additional appropriations to cover all activities contemplated in the legislation – and the bill appears to need a pay-for because it increases the deficit.
Whether to require physician education, when to limit the doses prescribed to patients, and how to weigh societal abuse potential in approvals are the initial questions for the Opioid Policy Steering Committee.