US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain
Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.
You may also be interested in...
The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.
Merck’s latest pneumococcal vaccine and Pfizer’s RSV vaccine notched new BTDs, along with Zambon’s inhaled antibiotic for non-CF bronchiectasis, Acer’s vascular Ehlers-Danlos syndrome drug and Dizal’s targeted lung cancer candidate.
FDA has a series of potentially high-profile advisory committees lined up to kick off 2022. One key underlying theme: whether and when the agency should use advisory committees to combat the perception of undue political pressure.