FDA is announcing a new draft guidance for industry, Quality Considerations for Topical Ophthalmic Drug Products. Ophthalmic drug products refer to any FDA-regulated drug products that are used for topical delivery around the eye such as solutions, suspensions, emulsions, gels, ointments or creams.
This draft guidance articulates important quality considerations for ophthalmic topical drug products, including:
- approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products;
- use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms;
- recommendations for design and delivery dispensing features of container closure systems; and
- recommendations for stability studies.
The guidance applies to ophthalmic drug products approved under new drug applications, abbreviated new drug applications, biologics license applications, as well as to over-the-counter monograph drugs.
To read the guidance and for more information on how to submit comments to the docket, visit the guidance page.
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