Oct 11, 2017· Comment from Association for Accessible Medicines· FDA-2017-D-2802-0008
The Association of Accessible Medicines (AAM) and the Biosimilars Council (Council) (collectively referred to in these comments as AAM), are pleased to provide comments to the Food and Drug Administration (FDA or the Agency) on the Agency's Draft Guidance on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports (Draft Guidance).