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 &...
Streamlining the Studies: New FDA Draft Guidance Aims to Speed Up Biosimilar Development
On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CES)...
Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private Intellectual Property Rights
Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought...
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