Federal Register Docket No. FDA-2017-D-0759
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” This draft guidance has been developed to provide industry with the Agency's current thinking for the development of human drug products, including those that are biological products, that contain nanomaterials. The draft guidance also includes recommendations for applicants and sponsors of investigational, premarket, and postmarket submissions for these products.
The FDA is requesting comments by March 19, 2018.
For full details, please visit: