1. Pink Sheet
  2. >>Pink Sheet Perspectives

US FDA’s Median Review Time Remains Less Than One Year Despite Swell Of Missed Goal Dates

 
• By Bridget Silverman

Novel agents from the biologics center had a median review time of 10.6 months, beating the drugs center's median of 11.8 months thanks to fewer multicycle and more priority reviews.

Pink Sheet Perspectives
The US FDA stayed on top of review times for novel agents in 2024, keeping close to PDUFA timetables. (Shutterstock)
Key Takeaways
  • The time between submission and approval continued to creep upward in 2024, with a median of 11.7 months for the US FDA’s novel approvals.

The median review times for US Food and Drug Administration-approved novel agents in 2024 held very close to Prescription Drug...

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 Pink Sheet Perspectives

Precision Underlines US FDA’s 2025 Cancer, Neuroscience Candidates

 
• By Bridget Silverman

Top areas for potential 2025 approvals were shaped by R&D focused on increasingly tightly targeted therapies, including the eight new candidates to join the still-burgeoning kinase inhibitor class and RNA interference, as well as many varieties of antibodies.

Novel Agents Up For US FDA Approval In 2025

 
• By Bridget Silverman, Nancy Pham, and Kosh Naran

CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.

Balancing Competitiveness and Sustainability In EU Regulations, What’s Next For Pharma

 
• By Francesca Bruce

Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.

More Heart, Less Skin: US FDA’s 2025 Novel Approvals Should Reflect Pipeline Shifts

 
• By Bridget Silverman

Only one-third of novel agents with 2025 goal dates come from the traditional oncology, hematology and neuroscience strongholds. Immunodermatology also is cooling, while cardiovascular drugs return to the front burner.

More from Regulatory Trackers

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

Global Pharma Guidance Tracker - April 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.