What emerging trends in the FDA’s most coveted designations might tell us

Marked shifts in the pursuit and grant of high-order designations raise fascinating questions. What factors might be driving the sharp downturns in CDER breakthrough designations? And does the sharp post-pandemic upturn in high-order designations by CBER represent a shifting of enthusiasm in favor of advanced therapies? This report, analyzing recent data from the FDA, gives critical insights into market shifts in high-order designations and what it might mean for drug developers.


Open PDF

Return to Insights Center

Related Insights

Article

8 things you need to know about eCTDs in China

Jul 1, 2022

Video

Overcoming asset transfer challenges during a merger and acquisition (M&A)

Oct 20, 2021

Article

Expedited Pathways Comparisons - US EU CHN

Oct 19, 2021

Webinar

Accelerated Early Phase Decision-Making – Insider Insights to Speed Development

Jan 7, 2025

Playbook

Early-phase development strategies for navigating regulatory complexity in the EU

Apr 29, 2024

Webinar

Assessing appropriate use of ECAs in clinical trials

May 28, 2023

Blog

Proof of product safety and efficacy: how to move ahead successfully in Phase 2 clinical development

Jan 22, 2025

Blog

Overcoming risks in Phase 3 trials to accelerate time to market

Jan 22, 2025

Blog

Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

Nov 19, 2021

Playbook

Streamlining development in the EU: Strategies for smoother CTA submissions

Feb 27, 2025

Article

Near-term strategies for biotech drug developers facing shifting healthcare dynamics

Feb 14, 2024

Article

How a joined-up development strategy pays off for early-stage biotechs

May 19, 2021

Related Insights

Article

8 things you need to know about eCTDs in China

Jul 1, 2022

Video

Overcoming asset transfer challenges during a merger and acquisition (M&A)

Oct 20, 2021

Article

Expedited Pathways Comparisons - US EU CHN

Oct 19, 2021

Webinar

Accelerated Early Phase Decision-Making – Insider Insights to Speed Development

Jan 7, 2025

Playbook

Early-phase development strategies for navigating regulatory complexity in the EU

Apr 29, 2024

Webinar

Assessing appropriate use of ECAs in clinical trials

May 28, 2023

Show more