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FDA Draft Guidance, "Drug Products, Including Biological Products, that Contain Nanomaterials" open for comment

The FDA recently published a draft guidance document for “Drug Products, Including Biological Products, that Contain Nanomaterials.” The draft guidance document can be downloaded here: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm588857.pdf

The FDA is requesting public comments on the draft guidance. They are also seeking comment on the terminology, including the term “nanomaterial”, as used in the draft guidance. The Federal Register notice can be found here: https://www.federalregister.gov/documents/2017/12/18/2017-27133/drug-products-including-biological-products-that-contain-nanomaterials-draft-guidance-for-industry

Comments are due by March 19, 2018.