The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more
With the second session of the 117th Congress underway, stakeholders are poised for another busy legislative session set against the dynamic backdrop of an ongoing global pandemic and midterm election year. Numerous...more
On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar...more
Nearly 30 years ago, the first law authorizing the Food and Drug Administration (FDA) to collect fees from drug manufacturers to expedite the review of new prescription drug applications was enacted. Since then, additional...more
On August 19, 2019, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that a proposed collection of information on the Review Transparency and Communication in Reviews of 351(k) Biologics License...more
Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans...more
Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more
On July 12, the House passed a five-year reauthorization of four different user fee agreements that account for over a quarter of the Food and Drug Administration's (FDA) overall funding. The legislation, titled "The Food and...more
The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the...more
Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging....more
The FDA has announced the rates for biosimilar user fees for the 2017 Fiscal Year... The biosimilar user fees for a given fiscal year are calculated as a percentage of the fee rate established under the Prescription Drug...more