Drugs

Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access

Meeting Information

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:

  1. Provide an overview of current regulatory science initiatives related to generic topical dermatological drug products
  2. Solicit public input on scientific barriers that may limit patient access to such drug products
  3. Discuss approaches to overcome/address any such barriers

To register, please go to: Dermatological Drug Workshop Registration disclaimer icon. 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.

Meeting Agenda

Meeting Materials

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance.

Session I

Session II

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Session III 

  • 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
     

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Session IV

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Session V 

Session VI

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