US FDA Revises Draft Guidance On Eye Drops Quality With Microbiology Topics Section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.

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The US Food and Drug Administration revises its draft guidance on quality for eye drops and other topical ophthalmic products by adding information on microbiology-related topics on the suggestion of a California biopharma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.

The agency on 28 December published revision 1 to the draft following a total of 20 comments submitted on the initial it published in October

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