1. Pink Sheet
  2. >>Product Reviews
  3. >>Complete Response Letters

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.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Complete Response Letters

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 
• By Dexter Jie Yan

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

US FDA Spikes Vanda’s Hetlioz For Insomnia, Lack Of Well-Controlled Trial ‘Fatal’

 
• By Sue Sutter

Acting Commissioner Sara Brenner rejected the company’s request for a hearing, saying the lack of an adequate and well-controlled trial showing tasimelteon's effectiveness in treating sleep-onset insomnia is “fatal to the application.”

Better Luck Next Year: US FDA CRLs May Be Rising, But Are Not The End Of The Story

 
• By Bridget Silverman

Prospects are promising for many of the 16 novel candidates that received complete response letters in 2024 after half of the 2023 CRL class was approved the following year.

More from Product Reviews

US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 
• By Bridget Silverman

All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.