1. Pink Sheet
  2. >>Pink Sheet Perspectives

Will US FDA Advisory Committees Rebound In 2023?

 
• By Michael McCaughan

The US FDA’s use of outside expert advisory committees rebounded from historic lows in 2022 – but just barely. Will Commissioner Califf’s ‘update’ of the process finally mean more committee meetings in 2023?

advisory committee rebound
After a small rebound in 2022, changes to the advisory committee system are in play for 2023. • Source: Shutterstock

Maybe the advisory committee drought isn’t over after all.

The US Food & Drug Administration did end up holding more advisory committee meetings for new drug applications in 2022 than it did in the record low year of 2021...

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 Pink Sheet

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.