Rare Disease Month Developments, Part 2 –The Bad: Proposed Closing of an Orphan User Fee “Loophole” & Renewed Concerns Regarding FDA Consistency February 18, 2026 By James E. Valentine & Sara W. Koblitz & Mark A. Tobolowsky —

https://www.thefdalawblog.com/2026/02/rare-disease-month-developments-part-2-the-bad-proposed-closing-of-an-orphan-user-fee-loophole-renewed-concerns-regarding-fda-consistency/?utm_source=rss&utm_medium=rss&utm_campaign=rare-disease-month-developments-part-2-the-bad-proposed-closing-of-an-orphan-user-fee-loophole-renewed-concerns-regarding-fda-consistency Rare Disease Month Developments, Part 1 – The Good: RPD PRV Program Renewed, FDA Rare Disease Hub’s 2026 Strategic Agenda & Plausible Mechanism Draft Guidance On Its Way February 17, 2026 By Mark A. Tobolowsky & James E. Valentine & Frank J. Sasinowski — https://www.thefdalawblog.com/2026/02/rare-disease-month-developments-part-1-the-good-rpd-prv-program-renewed-fda-rare-disease-hubs-2026-strategic-agenda-plausible-mechanism-draft-guidance-on-its-way/?utm_source=rss&utm_medium=rss&utm_campaign=rare-disease-month-developments-part-1-the-good-rpd-prv-program-renewed-fda-rare-disease-hubs-2026-strategic-agenda-plausible-mechanism-draft-guidance-on-its-way