Xiaochuan Yang
Xiaochuan Yang, PhD is with the Center for Drug Evaluation and Research, FDA
Articles
Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry
Geoffrey Wu;Lane Christensen;Thomas O’Connor;Frank Holcombe Jr.;Susan Rosencrance;Andre Raw;Kristina Adams;Xiaochuan Yang;Min Li
September 1st 2015An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
Latest Updated Articles
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: February 23rd 2024 | Updated: December 22nd 2024
Europa Perspectives: Helping to Navigate the Regulatory System
Published: December 13th 2024 | Updated: December 22nd 2024
FDA Creates CDER Center for Real-World Evidence Innovation
Published: December 5th 2024 | Updated: December 22nd 2024
Leveraging Advancements in Bioanalytical Testing
Published: December 7th 2024 | Updated: December 22nd 2024
Exploring Opportunities for LNP Delivery in mRNA
