Valisure’s Message To The FDA: It’s Part Of The Solution, Not Part Of The Problem
Executive Summary
CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.
You may also be interested in...
Non-Compendial Product Quality Screening Draws US FDA’s Criticism
Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.
Non-Compendial Product Quality Screening Draws US FDA’s Criticism
Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.
Valisure Aims To Show DOD, Others Which Generics Are Best In NDC Screening And Color-Coding Pilot
DOD signs R&D agreement with lab to double check quality of given FDA-approved generic drugs prior to dispensing them. Pilot could help the military and others identify higher-quality sources. Meanwhile, Kaiser pilots Valisure certification requirement.