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Home » FDA Outlines BsUFA II Fee Structure in Draft Guidance
FDA Outlines BsUFA II Fee Structure in Draft Guidance
The FDA published a draft guidance explaining the new biosimilar fee structure under BsUFA II and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay and how to request reconsiderations of fee assessments.