D1S09-Solana-Sodeinde-v1.2-FINAL.pdf

《D1S09-Solana-Sodeinde-v1.2-FINAL.pdf》由会员分享，可在线阅读，更多相关《D1S09-Solana-Sodeinde-v1.2-FINAL.pdf（26页珍藏版）》请在三个皮匠报告上搜索。

1、Using FDAs Inactive Ingredient Database(IID):Best Practices&ConsiderationsGeneric Drugs Forum(GDF)2026 April 22,202611:25 AM 11:45 AM ETCDR Diana Solana-Sodeinde,PharmD,MPHOffice of BioequivalenceOffice of Generic DrugsCenter for Drug Evaluation and Research3OutlineOverview of the IIDBest Practices:

2、How To Use the IIDHow to Calculate MDEGDUFA IID Program EnhancementsSpecial Considerations:FD&C Red#3Helpful Resources,IID Mailbox&Contact Informationwww.fda.gov4Overview:What is the IID?www.fda.gov5www.fda.gov6Introduction to the IID Inactive Ingredient Search for Approved Drug Products(fda.gov)|Us

3、ing the Inactive Ingredient Database Guidance for Industry|FDA The IID provides information on excipients present in FDA-approved drug products.Helpful Resources:FAQsGuidance for Industrywww.fda.gov7Best Practices:How to Use the IIDwww.fda.gov8How to Use the IID Inactive Ingredient Search for Approv

4、ed Drug Products(fda.gov)Enter any portion of the name of an excipient to search(enter at least three characters)Download the entire IIDwww.fda.gov9How to Use the IID(cont.)CAS=Chemical Abstracts Service Registry NumberUNII=Unique Ingredient Identifier assigned by FDAs Global Substance Registration

5、System(GSRS)Maximum Potency per unit dose Displays one row per unique Inactive Ingredient RoA DF combinationMaximum Daily Exposure(MDE)Recordwww.fda.govFlag for new records10Limitations of the IIDDoes not provide context of use(e.g.,duration of exposure,patient population,and indication(s)for use)Do

6、es not disclose proprietary excipient information(e.g.,reference listed drug formulation)Does not provide a link between maximum potency and MDEDoes not include excipients in Biologics License Applications and Over-the-Counter monograph productswww.fda.gov*Using the Inactive Ingredient Database Guid