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Session 6: Complex Topical and Transdermal Drug-Device Combination Products
Session Chair(s)
Karthik Balasubramanian, PhD, MS
VIce President, CMC & Technical Operations
Verrica Pharmaceuticals, United States
Sam G. Raney, PhD, MS
Associate Director for Science, ORS, Office of Generic Drugs, CDER
FDA, United States
A good understanding of how critical material attributes (CMAs), critical quality attributes (CQAs), and critical design attributes (CDAs) can impact a pharmaceutical product is essential to adequately control the quality, safety and effectiveness of the product. Yet, for complex topical and transdermal drug-device combination products, it may not always be clear what attributes may be critical to product quality and/or performance. This session will explore how to adequately mitigate known and unknown product risks while enabling the availability of high quality, safe and effective topical and transdermal drug-device combination products.
Specific topics to be explored will focus on recommendations in two recent FDA Guidances for Industry:
- Draft guidance for Industry, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA (Jan 2017)
- Draft guidance for industry on Transdermal and Topical Delivery Systems – Product Development and Quality Considerations (Nov 2019)
Learning Objective : - Identify CMAs, CQAs and/or CDAs of topical and transdermal drug-device combination products
- Explain key elements of comparative analyses for topical and transdermal drug-device combination products
- Implement recommendations in FDA guidances that are consistent with the intent behind the recommendation
- Recognize challenges for industry to develop generic topical and transdermal drug-device combination products
Speaker(s)
An FDA Perspective on the Comparative Analyses of Critical Material, Quality and Design Attributes for Topical, Transdermal, Rectal and Vaginal Drug-Device Combination Products
Megan Kelchen, PhD
FDA, United States
Reviewer (Chemist), OGD, ORS, CDER
Industry Experience with Comparative Analyses of Topical and Transdermal Delivery Systems
Saleh Rifaat
Teva Pharmaceuticals, United States
Senior Director, R&D
An FDA Perspective on TDS Product Development and Quality Considerations
Meenal Chavan, PhD
FDA, United States
Chemist, OLDP, OPQ, CDER
Case Study: Industry Experience with TDS Product Development and Quality Considerations
Michael Kimball, MS
Teva Pharmaceuticals, United States
Vice President, Generics R&D
Case Study: Industry Experience with TDS Product Development and Quality Considerations
Kuljit Bhatia, PhD
Mylan, United States
Head of Global Dermatologics R&D and Scientific Affairs
Panel Discussion
All Session Speakers, United States
Panelist
Robert Berendt, PhD
FDA, United States
Branch Chief, Division of Immediate & Modified Release Products III, OLDP, OPQ,
Panelist
Irene Z. Chan, PharmD
FDA, United States
Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE,
Panelist
Andrew Fine, PharmD
FDA, United States
Clinical Team Leader, Office of Generic Drugs
Panelist
Priyanka Ghosh, PhD
FDA, United States
Acting Team Lead, ORS, Office of Generic Drugs, CDER
Panelist
Kaushalkumar Dave, PhD, MPharm
FDA, United States
Biopharmaceutics Reviewer, Office of New Drug Products
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