仿制药标签最佳实践-Chan.pdf

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1、Best Practices for Generic Drug LabelingChurg“Stella”Chan,PharmD,BCPSDivision of Labeling Review(DLR),Office of Regulatory Operations(ORO),Office of Generic Drugs(OGD)CDER|US FDAGeneric Drugs Forum 2025 April 9,2025fda.gov/cdersbia2Learning Objectives Discuss best practices to update abbreviated new

2、 drug application(ANDA)labeling following revisions to the approved labeling of a reference listed drug(RLD).Review best practices for addressing patents and exclusivities as it relates to generic drug labeling.Provide updates on the current best practices on distributing electronic labeling.fda.gov

3、/cdersbia3Updating ANDA Labeling Following Revision of the RLD Labelingfda.gov/cdersbia4Background Generic drugs are required to have the same labeling as the RLD,except for differences allowed under Section 505(j)(2)(A)(v)of the Act and 21 CFR 314.94(a)(8).Applicant expected to update labeling at t

4、he earliest time possible after FDA has approved labeling for the corresponding RLD.fda.gov/cdersbia5 Labeling for non-marketed ANDAs that are not withdrawn must also be the same as the most recently approved RLD label.If the RLD is withdrawn,refer to the draft guidance titled“Updating ANDA Labeling

5、 after the Marketing Application for the Reference Listed Drug has been Withdrawn”.Labeling Updates for Non-Marketed ANDAsfda.gov/cdersbia6Generic drugs must update their labeling to be in PLR format when the RLD labeling is approved with PLR format.PLR format labeling:Communicates accurate and up-t

6、o-date information on the safe and effective use of drugs,Reduces the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information,and Makes the PI more accessible for use with electronic prescribing tools and other electronic information