D2S05-Bai-v1.2-FINAL.pdf

1、Pre-ANDA Meetings for Complex Drug ProductsSherry Bai,PhDDivision IV,Office of Product Quality Assessment IOPQ|CDER|US FDASBIA Generic Drug Forum April 22-23,2026Dos and Donts from the Quality Perspectivewww.fda.govwww.fda.gov2Overview Strategic use of the right communication for Pre-ANDA Communicat

2、ion What Makes a Drug Product Complex Pre-ANDA Meeting Package Contents and Stages Dos and Donts for PDEV and PSUB Meetings Summarywww.fda.govwww.fda.gov3What Makes a Drug Product“Complex”Complex Active IngredientThe active ingredient is not a simple,single chemical entity,e.g.,glatiramer acetate,pr

3、otamine sulfateComplex FormulationThe drug is delivered via a sophisticated formulation or physical form,e.g.,iron sucrose,propofolComplex Route of DeliveryLocally acting drugs,e.g.,desonide emulsion,prednisolone acetate suspension,brimonidine gelComplex Dosage FormTransdermal systems,e.g.fentanyl p

4、atches;metered-dose inhalers,e.g.albuterol MDIComplex Drug-Device CombinationThe product consists of both a drug and a device,where the device is integral to the drugs delivery,safety,or effectiveness,e.g.,epinephrine auto-injector,fluticasone nasal sprayGDUFA III Commitment letterNote:Products may

5、fall into multiple categorieswww.fda.govwww.fda.gov4Pre-ANDA CommunicationsRecommendations on bioequivalence(BE)/pharmaceutical equivalence(PE)studiesFor targeted scientific questions not answered in the PSGFor complex issues requiring in-depth dialogue and data reviewYour foundational resource for

6、established FDA recommendationsBest for narrow,specific scientific or regulatory questions that do not require in-depth data review or discussion.Reserved for when CC is not adequate,or when meetings would improve assessment efficiencyAlways check here firstBe specific and focusedCome prepared with