New FDA Program Prioritizes Review of Certain ANDAs
On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic companies...
The FDA Drops New Laboratory Test Regulations
Laboratory-developed tests (“LDTs”) are in vitro diagnostic (“IVDs”) products designed and used within a single clinical laboratory to perform high complexity testing. These tests can identify a wide range of issues...
Mitch Hadley Featured in Bloomberg Law New York Brief Q+A
In Bloomberg Law’s New York Brief Q+A series profiling top lawyers in the New York metro area, Mitch Hadley, Managing Partner of Knobbe Martens’ New York office, shared insights into...