FDA to Hold Public Meeting on Proposed Medical Device Review Recommendations
Key Takeaway: The FDA announced a public meeting and request for comments on proposed Medical Device User Fee Amendments (MDUFA )recommendations for fiscal years 2028-2032, which would govern medical device...
Practical Application and Particular Treatment: What the USPTO’s December 4 Memorandum Means for Life Sciences §101 Eligibility
The USPTO’s December 4, 2025 memorandum on Subject Matter Eligibility Declarations (SMEDs) seeks to raise awareness of the “underutilized path” of submitting Rule 132 declarations, referred to as “SMEDs”, for...
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...
