On March 3, 2026, the U.S. Food and Drug Administration (FDA) announced the publication of its new draft guidance “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers” ("NCIE...more
FDA has undergone fundamental changes under the Trump administration. The agency is smaller, but is it smarter? Commissioner Makary has embraced AI and appears to be looking for new ways to abbreviate clinical development for...more
2/18/2026
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Competition ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Healthcare ,
Induced Infringement ,
Interchangeability ,
Labeling ,
Off-Label Use ,
Orange Book ,
Patent Litigation ,
Pharmaceutical Industry ,
Research and Development
On February 3, 2026, President Trump signed into law the Mikaela Naylon Give Kids A Chance Act as part of the Consolidated Appropriations Act (CAA) of 2026. The CAA codifies FDA's interpretation of the scope of orphan drug...more
2/10/2026
/ Clinical Trials ,
Consolidated Appropriations Act (CAA) ,
Enforcement Actions ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Legislation ,
Orphan Drugs ,
Penalties ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Statutory Interpretation