BioSimilar FDA Extends Wait for Biosimilar Interchangeability Guidance Thomas Sullivan Jan 26, 2017 0 The United States Food and Drug Administration (FDA) was expected to release interchangeability guidance on biosimilars sometime…
FDA FDA Releases Draft Guidance on Manufacturer Communications with Payors,… Thomas Sullivan Jan 26, 2017 0 In mid-January 2017, the United States Food and Drug Administration (FDA) released a guidance document, entitled “Drug and Device…