The US Food and Drug Administration 505(b)(2) New Drug Application (NDA) pathway allows sponsors to use existing public data in lieu of conducting nonclinical and clinical studies, potentially offering significant drug development and marketing advantages. Nonclinical testing programs for 505(b)(2)...
Expertise: Nonclinical 4 results
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).1 Instead, within 3-5 years, the expectation will be to leverage an integrated safety...
Consulting
Madelyn “Mimi” Huang, Ph.D.
Nonclinical