Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: Quality Considerations for Topical Ophthalmic Drug Products; Draft Guidance for Industry; Availability, (Oct 13, 2023)

By WK Editorial Staff

The FDA is announcing the availability of a draft guidance for industry entitled “Quality Considerations for Topical Ophthalmic Drug Products.”

This draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. Specifically, this draft guidance discusses approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug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 and dispensing features of container closure systems; and recommendations for stability studies. The draft guidance applies to ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs. (Notice, 88 FR 70997, October 13, 2023).

Dates. Submit either electronic or written comments on the draft guidance by December 12, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews DrugBiologicNews GenericDrugNews OTCNews PrescriptionDrugNews SafetyNews