Guideline

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Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products
Internet:	http://www.fda.gov/oc/combination/OCLove1dft.pdf
Origin/Publisher:	FDA
Content:	This document provides guidance to industry and FDA staff on the applicability of current good manufacturing practice2 provisions to combination products as defined under 21 CFR 3.2(e). Such provisions apply to the manufacture3 of combination products to ensure that (1) the product is not adulterated; (2) the product possesses adequate strength, quality, identity, and purity; and (3) the product complies with performance standards as appropriate for the marketed combination product.
Status:	Draft