Mar 3, 2020· Comment from Association for Accessible Medicines· FDA-2019-D-5743-0021
The Association for Accessible Medicines and its Biosimilars Council (referred to in these comments collectively as "AAM") appreciates the opportunity to submit these comments to the Food and Drug Administration's ("FDA's") draft guidance on Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act ("Draft Importation Guidance"), which was announced in the Federal Register on December 23, 2019. 84 Fed. Reg. 70557 (Dec. 23, 2019) (Docket No. FDA-2019-D-5743). Please find our full comments attached.