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FDA Issues Draft Guidance on Postapproval Manufacturing Changes to Biosimilar Products

​​​​​​​On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more

8/2/2024  /  Biosimilars , Comment Period , Draft Guidance , FDA Approval , Food and Drug Administration (FDA) , Interchangeability , Pharmaceutical Industry , Prescription Drugs , Reporting Requirements

FDA Issues Draft Guidance on Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products and Classification...

In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and...more

8/16/2023  /  Biologics , Biosimilars , Draft Guidance , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Sponsors
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