Squires Again Broadens Discretion for Post-Grant Proceedings
On Wednesday, March 11, 2026, United States Patent and Trademark Office (USPTO) Director John Squires issued a memorandum[1] announcing...
Back to the Well: FDA’s Draft Guidance on New Clinical Investigation Exclusivity
- Introduction
FDA recently published a new draft Guidance for Industry titled “New Clinical Investigation Exclusivity (3-Year Exclusivity)...
Oliver Twisted Again: After FDA's Court Losses, Congress Approves FDA's Standards on Orphan Drug Exclusivity
Last week, Congress enacted the Consolidated Appropriations Act of 2026. This legislation narrows the scope of the statutory...
No More Needles in Haystacks: Congress Requires FDA to Explain Q1/Q2 Sameness
Last week, on February 3, 2026, Congress passed the Consolidated Appropriations Act (“the Act”), providing generic drug manufacturers...
Here We Go Again: Third Round of Inflation Reduction Act Drugs Listed
Pursuant to the Inflation Reduction Act (the “IRA”), the Secretary of Health and Human Services (“HHS”) and the Center for Medicare &...
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