US FDA’s Coronavirus Workload Shifting Beyond Idea Stage
Executive Summary
Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.
You may also be interested in...
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.
US FDA Sets User Fees For FY2021
ANDA submission rate increases, while the NDA and BLA fee drops and the biosimilar fee is unchanged.
US FDA Sets FY 2021 User Fees, With Coronavirus (Somewhat) In Mind
ANDA submission rate increases, while the NDA and BLA fee drops and the biosimilar fee is unchanged.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: