Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

As Pandemic Delays Reduce PDUFA Revenues, US FDA Slows Fee-Related Spending

Mar 08 2021

• By Bowman Cox

Dominoes falling on gray background — Signs have emerged that the pandemic slowed the pace of new drug applications. • Source: Shutterstock

Related Content

Full Extent Of Clinical Trial Damage May Be Unknown Until Pandemic Ends, CBER’s Peter Marks Says

Oct 14 2020

The Big Spend-Down: US FDA Eyes $159M Reduction In Carryover User Fees

Apr 08 2018

FDA May Not Implement User Fee Workload Adjuster In PDUFA VI

Apr 02 2018

US FDA Sets FY 2021 User Fees, With Coronavirus (Somewhat) In Mind

Aug 01 2020

How The US FDA Finds Pre-Approval Inspection Alternatives During COVID-19 Pandemic

Jul 16 2020

Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII

Mar 04 2021

Biosimilar User Fee Revenue Missed Estimates Again In FY 2019, Spending Reduced

Jun 23 2020

Complete Response Letters In Lieu Of Inspections: What To Expect During COVID-19

Aug 20 2020

PDUFA Needs More Than 300 Additional FTEs, New US FDA Capacity Planning Formula Says

Aug 06 2020

Shutdown Deal Avoids Further US FDA Service Cuts, But Damage May Linger

Jan 26 2019

The Impact Of COVID-19 On Clinical Trials

Jun 08 2020

Additional Topics

United States Drug Review User Fees Clinical Trials Coronavirus COVID-19 FDA BioPharmaceutical

More from Product Reviews

More from Pink Sheet

About Us

Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us

Customer Service
SubscribeOpens in new window
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window