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USFDA Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two guidances earlier this week ie, "Quality Considerations for Topical Ophthalmic Drug Products" and "Stimulant Use Disorders: Developing Drugs for Treatment".

The guidance discusses certain quality considerations for ophthalmic pharmaceutical products (e.g., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical administration in and around the eye, 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.

Stimulant Use Disorder is defined as “a pattern of amphetamine-type substance, cocaine, or other stimulant use leading to clinically significant impairment or distress,” ranging from mild to severe.

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders.

FDA recommendations for drug development and clinical trial designs are addressed in this guidance. It contains recommendations for drugs that may support indications for treating moderate to severe cocaine use disorder, moderate to severe methamphetamine use disorder, or moderate to severe prescription stimulant use disorder.


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