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)...
William Salminen
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...
During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance,...
President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to...
One of the most common formulation issues that sponsors of new drug or biologic products face is the qualification of novel excipients. Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA)...