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.
FDA published five GMP drug warning letters and one to a device maker. FDA frequently requests “independent” assessments indicating that they do not think the firms are capable of performing these activities internally.
An FDA drug investigator reports on the ways SOPs and data can introduce unneeded risks in quality management systems.
Enforcement this week included two drug GMP warning letters, both to firms in the US.