FDA's requirements for quality research of ophthalmic preparations and its enlightenment
On December 28,2023,the U.S.Food and Drug Administration(FDA)issued"Quality Considerations for Topical Ophthalmic Drug Products Draft Guidance for Industry"The guidance revised the draft guidance of the same name released in October 2023.Considerations for some quality studies of ophthalmic products intended for topical administration into and around the eye,including gels,ointments,creams,and liquid formulations such as solutions,suspensions,and emulsions,are discussed,covering five aspects of quality research:Microbiology,visible particulate matter,extractables and leachables,impurities and degradation products,and stability research,and elaborates on relevant suggestions for design of container closure system(CCS),etc.This article introduces the main contents of the FDA's guidance in detail,hoping to shed some light on the research and development of this type of drug.
US Food and Drug Administration(FDA)ophthalmic preparationsquality evaluationmicrobiologyvisible particulate matterimpurities and degradation productscontainer closure system(CCS)
NETL
NSTL
万方数据
