From Principle to Practice: Bugs, Drugs & Attachments (The US Regulatory Affairs Handbook)

From Principle to PracticeTM: Bugs, Drugs and Attachments; When Time Matters, Where to find it! This handbook is a compact easy-to-carry FDA regulatory quick reference handbook on US Regulatory Affairs. You must have it. Navigating the US Regulatory pathways from initial application to the FDA to market approval or clearance is a highly demanding process that is complete with many technical and regulatory challenges when presented with unanticipated program changes; busted timelines; wrong turns; or a Form FDA 483. Avoiding these pitfalls is what we are all trying to do. The life of your program may depend on it. This guide is a must for regulatory affairs professionals, as a guide and as a drug FDA regulatory handbook, or a biologics FDA regulatory handbook or a medical device FDA regulatory handbook. Use this as Your FDA Regulatory Quick Reference Resource for INDs, IDEs, NDAs, BLAs, 510(k)s, PMAs, OTCs, ANDAs, HUDs, HDEs, IVDs, and more.