D1S21-Rajesh-v1.2-FINAL.pdf

1、Drug-Device Combination Products:A Quality PerspectiveSheela Rajesh,PhDSenior Pharmaceutical Quality AssessorDivision of Product Quality Assessment IXOffice of Product Quality Assessment II(OPQA II),Office of Pharmaceutical Quality(OPQ)CDER|US FDASBIA Generic Drug Forum April 22,2026www.fda.gov2Disc

2、laimerThis presentation is not intended to convey formal FDA policywww.fda.gov3Presentation Outline Introduction of Drug Device Combination Products(DDCPs)Assessment team structure&process for generic DDCPs Drug Product critical quality tests for Parenteral products Recommended Performance tests of

3、DDCPs Common deficiencies in generic DDCPs Case studieswww.fda.gov4What is a Combination Product?A product comprised of two or more regulated components:drug/device,biologic/device,drug/biologic or drug/device/biologic per 21 CFR 3.2(e)Current Good Manufacturing Practice(CGMP)Requirements for Combin

4、ation Products:21 CFR Part 4&21 CFR 4.4(b)(2)Drug CGMP:21 CFR parts 210 and 211 Device:Quality Management System Regulation(QMSR):21 CFR part 820 www.fda.gov5CDER as Lead Center Primary mode of action(PMOA)is the single mode of action of a combination product that provides the most important therape

5、utic action of the combination product(21 CFR 3.2(m).Drug provides the PMOA:CDER is Lead Centerwww.fda.govTherapeutic Equivalence-DDCPA generic combination product classified as therapeutically equivalent to the RLD can be expected to produce the same clinical effect and safety profile as the RLD un

6、der the conditions specified in labeling confirm that the differences in device and labeling for the proposed generic combination product are acceptable and that the proposed generic combination product can be substituted with RLDwww.fda.gov7 Per 21 CFR part 3.2(e),combination products include:Singl