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.
FDA posted four GMP drug warning letters, all to firms outside the US. One of the letters reinforces the need to monitor import alerts to ensure that suppliers and CMOs are not on the list; the consequences of missing this can be serious as this firm learned.
The FDA 510(k) Program, also referred to as premarket notification, is an FDA marketing clearance application and is the most common avenue of premarket submission for medical devices. This article serves to provide you with a high-level understanding of the items required in 510(k) submissions and resources to help you during the process.
This week we cover three warning letters: two to pharma firms and one to a clinical investigator.
Among FDA-posted warning letters this week, the Center for Tobacco Products posted four warning letters, one GMP drug warning letter from CDER and yet another, the 4th, warning letter regarding failure to comply with the Foreign [Food] Supplier Verification Program (FSVP) posted this week.
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.
FDA posted three drug warning letters this week, one of which was issued regarding combination products. FDA’s requests for “independent” assessments continue.