Quality considerations for topical eye treatments: FDA publishes new draft guidance

On the heels of con­t­a­m­i­na­tion con­cerns, the FDA on Thurs­day pub­lished draft guid­ance on qual­i­ty con­sid­er­a­tions for top­i­cal eye treat­ments, di­rect­ing man­u­fac­tur­ers to eval­u­ate vis­i­ble par­tic­u­late mat­ter and lay­ing out con­sid­er­a­tions for pack­ag­ing.

The 15-page guid­ance lays out four main ar­eas of con­sid­er­a­tion — eval­u­at­ing vis­i­ble par­tic­u­late mat­ter, us­ing in vit­ro drug re­lease/dis­so­lu­tion test­ing as a qual­i­ty con­trol strat­e­gy, rec­om­men­da­tions for con­tain­er clo­sure sys­tems, and rec­om­men­da­tions for sta­bil­i­ty stud­ies.

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