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Keeping Track: Incomplete Responses For Unusual Times; Qtrypta Is Latest CRL

 
• By Bridget Silverman

Highlights from complete response letter news from the Pink Sheet’s US FDA Performance Tracker.

Keeping Track Feature image

The difficulties of conducting manufacturing inspections and review activities in the COVID-19 era seems to be encouraging the FDA to find a response that is less definitive than a complete response letter and less formal than a user fee goal date extension.

Spectrum Pharmaceuticals Inc. became the latest recipient of a “not a complete response” letter upon the 24 October 2020...

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More from US FDA Performance Tracker

Single Trial Success Stories: UCB’s Kygevvi Joins US FDA Approvals With Confirmatory Evidence

 
• By Bridget Silverman

The orphan drug share of US FDA’s 2025 novel approvals is holding steady, with examples of approvals based on a single trial with confirmatory evidence from UCB, Precigen, Jazz Pharmaceuticals and Stealth Biotherapeutics

Do US FDA Complete Response Letters Suggest Turn To Less Flexibility In Rare Disease?

 
• By Bridget Silverman

A cluster of CRLs for rare disease applications based on one trial plus confirmatory evidence may represent a shift away from the regulatory flexibility that had come to characterize ultra-rare drug development

Novel US FDA Approvals Could Heat Up November, But Will Annual Count Beat 2024?

 
• By Bridget Silverman

Eight novel agents have user fee goal dates in November, which keeps the possibility of matching or topping the 2024 annual count alive.

Cidara’s Non-Vaccine Flu Preventive Offers Respite From Vaccine Conflicts

 
• By Bridget Silverman

Cidara's CD388 drug-Fc conjugate received a breakthrough designation as the Phase III ANCHOR trial started for once-per-season prevention of influenza in a higher-risk population.

More from Regulatory Trackers

Novel US FDA Approvals Could Heat Up November, But Will Annual Count Beat 2024?

 
• By Bridget Silverman

Eight novel agents have user fee goal dates in November, which keeps the possibility of matching or topping the 2024 annual count alive.

Cidara’s Non-Vaccine Flu Preventive Offers Respite From Vaccine Conflicts

 
• By Bridget Silverman

Cidara's CD388 drug-Fc conjugate received a breakthrough designation as the Phase III ANCHOR trial started for once-per-season prevention of influenza in a higher-risk population.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.