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Drug Rejection Hearings Are Having A Moment At US FDA

 
• By Brenda Sandburg

With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.

Hanging On
Intarcia gets last chance to challenge FDA's rejection of its new drug application for diabetes treatment. • Source: Alamy

The US Food and Drug Administration rarely issues a public announcement offering a sponsor the chance to request a hearing to defend a new drug application it plans to reject. But the agency now may have two such hearings pending.

Under FDA regulations governing “complete response” letters, companies may ask the FDA for a hearing on whether there are grounds...

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More from Complete Response Letters

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By Joseph Haas

Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

More from Product Reviews

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
• By Sue Sutter

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.