User Fee Renewal Negotiations Beginning This Week
Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.
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Woodcock's Prophesy Comes True: US FDA ANDA Approvals Decline From Record Levels
Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.
PDUFA VII Talks Begin With Similar Goals For Industry, US FDA
Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.
US FDA Needs ‘More Streamlined’ REMS Enforcement Authority, Inspector General Says
Additional power would allow the agency to punish 'simple' REMS violations and improve administration of risk management programs, according to a new report looking at FDA's oversight of opioids.