Back to the Well: FDA’s Draft Guidance on New Clinical Investigation Exclusivity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FDA recently published a new draft Guidance for Industry titled “New Clinical Investigation Exclusivity (3-Year Exclusivity)...
FDA recently published a new draft Guidance for Industry titled “New Clinical Investigation Exclusivity (3-Year Exclusivity)...
Last week, Congress enacted the Consolidated Appropriations Act of 2026. This legislation narrows the scope of the statutory...
Last week, on February 3, 2026, Congress passed the Consolidated Appropriations Act (“the Act”), providing generic drug manufacturers...
Pursuant to the Inflation Reduction Act (the “IRA”), the Secretary of Health and Human Services (“HHS”) and the Center for Medicare &...
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CES)...
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