Ophthalmic, Parenteral, & Otic Drug Development: Does FDA’s Draft Guidance Provide A Vehicle To Avoid Patent Problems?
In April 2022, FDA released a proposed draft guidance (FDA Dock. No. 2022-D-0108) involving pH adjusters in drug development relating to ophthalmic, parenteral, or otic drug products. The Draft Guidance suggests that FDA may entertain proposed ANDA formulations that differ in the pH adjuster in the ANDA formulation as compared to the Reference Listed Drug […]