COVID-19 Demands Merit A Mention In US FDA's PDUFA Fees Notice For FY 2021
The pandemic's impact was mentioned only in FDA's calculations for fees including those established by PDUFA. In addition to prescription drug applications, PDUFA fees are charged for OTC switch applications and other proposals for ingredients that are not part of an OTC monograph to be made available nonprescription.
You may also be interested in...
Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.
House appropriators don’t mention the consumer health market in requesting a report on FDA’s response to COVID-19, but the agency’s frequent warnings about products marketed with unlawful claims could merit mentioning. Encouraging accelerated production of hand sanitizers while also ensuring the additional supplies are safe is another component of its COVID-19 response that could be covered in an assessment of its response to the pandemic.
Syndax CEO also says US FDA’s virtual meetings would benefit from having advisory committee members on camera, which may be a technology challenge.