FDA-regulated firms face an enormous challenge keeping up with agency priorities and expectations—especially companies that produce older products within an ever-changing regulatory landscape. While firms continue to manufacture these older products to serve their customers and protect their brand, there are many potential quality compliance issues that can arise.
How to Talk So That FDA Will Listen, and How to Listen When They Talk: Advice That Could Be Worth Millions
Former FDA Team Leader and Pearl Pathways Senior Regulatory Advisor Dr. Robert Seevers shares his experience reviewing and submitting NDAs.
Govzilla and Valisure Announce A Collaboration Focused on Creating A Platform For Evidence-Based Quality Scores For Drug Products
The new platform will use AI to generate quality scores based on a combination of public FDA reports and Valisure’s chemical analysis of on-market drug products.
Join Govzilla’s GMP Quality Expert Jerry Chapman for an informative 1-hour webinar on assessing legacy products for potential GMP compliance gaps and pitfalls.
Over the years, the FDAzilla blog has published over 650 articles. We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.