Reviewing RMPs Against FDA's Drug Shortage Guidance, Inside FDA's Device VIP + Warning Letter Breakdown
We distill the key points from FDA's RMP-impacting drug shortage mitigation guidance, explore FDA's device voluntary improvement program, and break down a warning letter to a domestic drugmaker.
Welcome to Insider issue #7.
And welcome to the 92 new life science professionals who joined last month.
Today we’re looking at a new FDA draft guidance on creating and maintaining pharma Risk Management Plans (RMPs) to “help stakeholders develop, maintain, and RMPs to proactively assist in the prevention of human drug product and biological product shortages.” We cover some tactical steps RA/QA teams should consider taking in light of this guidance.
We’re also looking at FDA’s recently issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP) that uses third-party appraisals to evaluate manufacturing practices.
And lastly, we break down a Warning Letter issued to a domestic drug manufacturer for several GMP violations.
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