FDA’s Latest Guidance on Post-Approval Manufacturing Changes for Biosimilars Emphasizes Current Practices and New Dosage Forms: An Exclusive Analysis in Life Science
The FDA is enhancing its guidelines for biosimilar and interchangeable product applicants regarding post-approval manufacturing changes. The updated draft guidance focuses on new considerations for applicants looking to introduce new dosage forms or strengths, or to produce the product in facilities that also handle different versions of the biological product. This development is aimed at […]