Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.
|Articles|June 22, 2021
Managing Change Control Alongside Evolving Regulations
Author(s)MasterControl
In the highly regulated life sciences industry, effective change control is essential to your success. Our white paper “Managing change Control to Comply With FDA and EU Regulations” will show you how you can improve change control speed, efficiency, and compliance.
Related to this article
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.
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.
Jaenisch, Muraru, and Pandey join PharmTech's Cole to discuss FDA's generative AI paper, ARPA-H's SURPASS trials, and AI accountability.
Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.
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.
Trending on Pharmaceutical Technology
1
FDA Rare Disease Framework Puts CMC Review in Scope
2
Clinical Trial Delays: FDA’s Expedited IND Pilot vs China’s 818 Decree
3
PharmTech AI Pulse Check: AI Watermark Vulnerability
4
Manufacturing Intelligence: What FDA's Real-World Use Case Database Means for CMC
5