Search results for " cmc postapproval"
Article
Quality Systems Key to Lifecycle Drug Management
FDA, Guidance for Industry, CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (CDER, March 2014), www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/…
Article
Efforts Accelerate to Streamline Postapproval Change Process
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
By Jill Wechsler
Frequent revisions and updates in manufacturing processes and operations are routine…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
Breakthrough Drugs Raise Development and Production Challenges
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA pro…