3/10/2026 4:39:27 PM Back to the Well: FDA’s Draft Guidance on New Clinical Investigation Exclusivity By Aziz Burgy Aaron Savit Emalee Peterson Introduction FDA recently published a new draft Guidance for Industry titled “New Clinical Investigation Exclusivity (3-Year Exclusivity)...
2/12/2026 6:21:54 PM No More Needles in Haystacks: Congress Requires FDA to Explain Q1/Q2 Sameness By Ross Blau Jody Karol Emalee Peterson Last week, on February 3, 2026, Congress passed the Consolidated Appropriations Act (“the Act”), providing generic drug manufacturers...
2/6/2026 3:59:26 PM Here We Go Again: Third Round of Inflation Reduction Act Drugs Listed By Ross Blau Jody Karol Raymond Braha Emalee Peterson +1 more... Show less Pursuant to the Inflation Reduction Act (the “IRA”), the Secretary of Health and Human Services (“HHS”) and the Center for Medicare &...