FDA Guidance for Industry: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
Titel:
FDA Guidance for Industry: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
Internet:
Herkunft/Verlag:
FDA
Inhalt:
This guidance provides answers to commonly asked questions from applicants and other interested parties (collectively referred to as applicants throughout this guidance) regarding postapproval manufacturing changes (referred to as manufacturing changes throughout this guidance) made to licensed biosimilars and licensed interchangeable biosimilars