October 20, 2017 (8:00 am – 4:30 pm)
FDA White Oak Campus, Building 31, Great Room Section A
The workshop is free to attend and open to the public.
The FDA is conducting a public workshop to provide an overview of current regulatory science initiatives concerning generic topical dermatological drug products. Using funds from the Generic Drug User Fee Amendments (GDUFA), FDA directed research initiatives are aimed at affecting regulatory and scientific barriers that may adversely impact patient access to some generic topical dermatological drug products. These research initiatives have resulted in the development of enhanced tools for product characterization that could accelerate product development while reducing risk. Alternative approaches to evaluate bioequivalence for topical dermatological generic drug products that could be more efficient, more sensitive and reproducible will also be discussed.
The FDA believes that these evolving tools and approaches would benefit from public discussion, and is interested in receiving public feedback during this workshop. As part of this workshop, leading researchers from several institutions will discuss novel in vitro and in vivo approaches developed to characterize topical products and to compare topical bioavailability. In addition, speakers from the FDA will share regulatory perspectives, including review perspectives that may provide increased success for a generic topical dermatological drug development program, and ultimately, enhance patient access to these generic drug products. The focus of the workshop will be to:
- Provide an overview of current regulatory science initiatives related to generic topical dermatological drug products
- Solicit public input on scientific barriers that may limit patient access to such drug products
- Discuss approaches to overcome/address any such barriers
To register, please go to: Dermatological Drug Workshop Registration . Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m.
Webcast Link for Online Attendees: https://collaboration.fda.gov/ogddermaldrug/. Please log-in as guests.
The workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503 A), Silver Spring, MD 20993-0002.
Visitors attending public meetings in the Building 31 Great Room must enter through Building 1 where they will undergo the routine security check procedures for building entry. A visitor badge and escort are not required to attend a public meeting in the Great Room. Please allocate 15 - 30 min for arrival and security checks. Driving and parking information for visitors to the FDA, along with a campus map, can be found at: FDA White Oak Campus Visitor Information
FOR FURTHER INFORMATION CONTACT: Dr. Sam Raney, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4706, Silver Spring, MD 20993, 240-402-7967, email: Sameersingh.Raney@fda.hhs.gov; or Dr. Markham Luke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4712, Silver Spring, MD 20993, 301-796-5556, email: Markham.Luke@fda.hhs.gov.
Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance.
- Evolving Perspectives on Generic Drugs in the 21st Century (PDF - 1 MB)
John Peters, M.D.
Deputy Director, Office of Generic Drugs
- Overcoming Barriers and Improving Patient Access to Topical Dermatological Drugs (PDF - 647 KB)
Markham Luke, M.D., PhD
Director, Division of Therapeutic Performance (DTP)
- In Vivo Dermal Open Flow Microperfusion: A Novel Approach to Evaluating Topical Bioavailability and Bioequivalence (PDF - 3 MB)Video: https://collaboration.fda.gov/p1ls78ggr9p/
Frank Sinner, PhD
Director, Joanneum Research (Austria)
- Correlation of Physicochemical Characteristics and In Vitro Permeation Test Results for Acyclovir and Metronidazole Topical Products (PDF - 13 MB)
Michael Roberts, PhD
Professor and Research Chair: Therapeutics and Pharmaceutical Science
University of South Australia
- Characterizing the Critical Quality Attributes and In Vitro Bioavailability of Acyclovir and Metronidazole Topical Products (PDF - 3 MB)
S. Narasimha Murthy, PhD
Professor of Pharmaceutics
University of Mississippi
- Characterizing In Vitro Bioavailability of Acyclovir and Metronidazole Topical Products, and In Vitro – In Vivo Correlation Results with Transdermal Systems (PDF - 3 MB)
Audra Stinchcomb, PhD
Professor of Pharmaceutical Science
University of Maryland
- Prepared Public Comments
- Dr Annick ROUL (PhD) (PDF - 42 MB)
Colonel, Directorate of Civil Security and Crisis Management
Pharmacist Advisor for Directorate of Civil Security
and Crisis management
Ministry of Interior France
- Vinod P. Shah (PhD), FAAPS, FFIP. (PDF - 200 KB)
Pharmaceutical Consultant, VPS Consulting, LLC
North Potomac, MD., USA
- Dr. Kailas Thakker (PhD) (PDF - 621 KB)
Chief Operating Officer and Cofounder, Tergus Pharma
- Richard H. Guy (PhD) (PDF - 4MB)
Professor, University of Bath
University of Bath, U.K.
- Annette L. Bunge (PhD) (PDF - 358 KB)
Professor Emeritus, Colorado School of Mines
Colorado School of Mines, Golden, Colorado
- David W. Osborne, (PhD) (PDF - 95 KB)
Chair, Industry Q3 Working Group
Q3 Working Group
- Sebastian Polak (PhD) (PDF - 1.45 MB)
Assoc. Professor and Sr. Principal Scientist, Simcyp (Certara)
Jagiellonian University Medical College, Krakow, Poland
- Ravi S. Harapanhalli (PhD) (PDF - 602 KB)
Sr. VP of Global Regulatory Affairs, Amneal Pharmaceuticals
- The Journey from Developing the Research Studies to Drafting a New Regulatory Standard (PDF - 1MB)
Sam Raney, PhD
Scientific Lead, Division of Therapeutic Performance (DTP)
- In Vitro Bioequivalence Data for a Topical Product: Chemistry Review Perspective (PDF - 290 KB)
Pahala Simamora, PhD
Branch Chief, Division of Liquid-Based Products (DLBP)
- In Vitro Bioequivalence Data for a Topical Product: Bioequivalence Review Perspective (PDF - 1 MB)
Suman Dandamudi, PhD
Acting Team Lead, Division of Bioequivalence III (DBIII)
DBIII/Office of Bioequivalence (OB)/OGD/CDER/FDA
- Panel Discussion and Open Public Comment
- GDUFA Regulatory Science Research and the Future of Generic Drugs
Robert Lionberger, PhD
Director, Office of Research and Standards (ORS)