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FDA Revises Draft Guidance on Quality Considerations for Ophthalmic Drug Products

FDA Revises Draft Guidance on Quality Considerations for Ophthalmic Drug Products

January 05, 2024

The FDA has released a significant update for the pharmaceutical industry, unveiling a revised draft guidance titled "Quality Considerations for Topical Ophthalmic Drug Products." This comprehensive guidance addresses crucial quality considerations for various ophthalmic drug products, including gels, ointments, creams, and liquid formulations such as solutions, suspensions, and emulsions.

The key highlights of this revised draft guidance encompass a spectrum of topics essential for ensuring the efficacy and safety of ophthalmic drug products. Notably, it delves into microbiological considerations, strategies for evaluating visible particulate matter, extractables, leachables, impurities, and degradation products. Additionally, the guidance discusses the optional use of in vitro drug release/dissolution testing as a quality control measure for specific ophthalmic dosage forms.

The recommendations extend to design, delivery, and dispensing features of container closure systems, as well as guidelines for stability studies. Importantly, this guidance is applicable to a wide range of products, including those approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs). It also covers over-the-counter (OTC) monograph drugs, drugs compounded by outsourcing facilities, and the drug or biological product constituent part of a combination product.

This announcement signifies a commitment to upholding rigorous quality standards in the pharmaceutical industry. Stakeholders are encouraged to review and provide feedback on this updated guidance, which builds upon the draft issued in October 2023.

FDA urges everyone to submit either electronic or written comments on the revised draft guidance by February 26, 2024, to ensure that the Agency considers all comments on this revised draft guidance before it begins work on the final version of the guidance.



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