The US Food and Drug Administration revises its draft guidance on quality for eye drops and other topical ophthalmic products by adding information on microbiology-related topics on the suggestion of a California biopharma foundation and lobby group.
US FDA Revises Draft Guidance On Eye Drops Quality With Microbiology Topics Section
Bicom California suggests FDA add a section on microbiology-related topics relevant to ophthalmic products, which include OTC monograph drugs and Rx and nonprescription formulations available through approved applications.
