As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
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 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more
Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and...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
Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P...more
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...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
The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...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