Guidance Explains User Fee Structure for Biosimilars
The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.
FDA published final guidance on Jan. 23, 2020 that provides information regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the FDA Reauthorization Act of 2017. The guidance details the new fee structure and types of fees created as a result of BsUFA II.
Specifically, the guidance explains the process for submitting payments, the consequences for not paying BsUFA fees, and how to request reconsideration of a user fee assessment. FDA also describes how it determines which products are subject to fees. It does not, however, address how the agency determines and adjusts fees each fiscal year or how it addresses implementation of other user fee programs.
Source: FDA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
