
News|Videos|October 15, 2026
Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval, Part 1
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
This webinar, “Rare Pediatric PRVs: Manufacturing Strategies for Expedited Approval,” is moderated by Nate Edwards, engagement manager with ARYA Consulting Partners, with guests Elisabeth Gardiner, CSO, Tevard Biosciences; and Donny Xu, a policy analyst at the RTW Institute. In part 1, the guests explain the history of the Rare Pediatric Disease Priority Review Voucher (PRV) Program and the benefits and challenges of going through the PRV process.
Related to this article

This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.

FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.

This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.

The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.

NVIDIA’s $250M, five-year compute donation funds UK agentic AI safety research, with implications for how GMP teams validate and govern autonomous AI.

Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.

This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.

