Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products- Questions and Answers; Draft Guidance for Industry; Availability

The Association for Accessible Medicines (AAM), and its Biosimilars Council (collectively referred to in these comments as AAM), are pleased to submit comments to the draft guidance FDA-2019-D-5473 that addresses Food and Drug Administration (FDA) regulated promotional labeling and advertisements for products licensed under 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262). Please our full comments enclosed.