Where’s The Bolus? ANDA Projections For FY 2015 Don’t Reflect Past, Future Surges
This article was originally published in The Pink Sheet Daily
Executive Summary
Generic drug makers will face higher facility fees but lower application fees next fiscal year.
You may also be interested in...
Will PDUFA VI Fee Structure Changes Slow Revenue Growth?
User fee revenue expected to break $1bn threshold by FY 2020, but growth looks to be slower than last few years.
US FDA Commissioner Califf Takes On Misinformation, Starting With ‘Rumor Control’
Agency leader expects to spend about a year developing a strategy to combat misinformation. On 5 August, the agency unveiled what appears to be an early component of the initiative – a web page titled Rumor Control, with facts about the safety and components of COVID-19 vaccines.
Monkeypox Vaccine: US FDA Eyes Dose-Sparing Strategy For Jynneos
Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.