United States - Patent - Ophthalmic, Parenteral, & Otic Drug Development: Does FDA's Draft Guidance Provide A Vehicle To Avoid Patent Problems?

In April 2022, FDA released a proposed draft guidance (FDA Dock.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.

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, Generic Drug Companies , Draft Guidance , Reference Listed Drug , Generic Drug , Product Specific Guidance ,