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Regulatory

FDA Guidance Document

What is an FDA Guidance Document?
An FDA Guidance Document is a publication that the FDA puts out to give manufacturers (and others) insight into their current thinking around a particular topic. FDA Guidance Documents give additional clarity to manufacturers around what may or may not be acceptable and generally serves to help make decision-making easier for the company as they can more clearly assess risk v. benefit of taking a particular action.

FDA Guidance Documents can be searched on the FDA website.