Drug Products, Including Biological Products, That Contain Nanomaterials; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Drug Products, Including Biological Products, That Contain Nanomaterials." This guidance finalizes the draft guidance issued December 18, 2017, developed to provide industry with the Agency's current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance also includes recommendations for applicants and sponsors of investigational, premarket, and postmarket submissions for these products.