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Food and Drug Administration (FDA) Small Business Town Meeting For Pharmaceutical Industry

March 5, 2003
The FDA’s Center for Drug Evaluation and Research (CDER), Office of Regulatory Affairs (Central Region and Philadelphia District) are sponsoring a Town Meeting specifically targeted to help small drug companies understand regulatory requirements for approval and marketing. This provides an opportunity to dialogue with subject matter experts from CDER and the Field on a variety of topics of interest to the small business community. There is no charge for attendance, but seating will be limited, so please mark your calendars and plan to register early.

Date and Location:
Wednesday, March 5, 2003
12:00-4:00 PM
William J. Green Federal Building, 6th and Arch Street
Conference Rooms A & B, 2nd Floor
Philadelphia, PA 19106

Presentations to include:

  • OTC Monographs and Labeling - David Hilfiker, Supervisory Project Manager, Division of OTC Drug Products, CDER
  • Pre-IND Meetings and the FDA Meetings Process - Judit Milstein, Regulatory Project Manager, Division of Anti-Infective Drug Products; Office of Drug Evaluation, CDER
  • Communicating with the FDA - Navigating the FDA Website - Marie Falcone, Small Business Representative, ORA Central Region
  • Requirements for Importation and Exportation of Drug Products - Ada Irizarry, Senior Compliance Officer, Office of Compliance/CDER
  • The Drug Registration and Listing System - Kathy Y. Smith, Project Officer (Sr. Management Analyst) Drug Registration and Listing System (DRLS), Division of Data Management and Services (DDMS)/Office of Information Technology and David Mazyck, DRLS Manager, DDMS
  • Financial Incentives - Ronald Wilson, Director, Small Business Assistance, CDER

For further information please contact:

Ms. Marie Falcone, Small Business Representative
Central Region, FDA
Mfalcone@ora.fda.gov

Mr. Ron Wilson
Director, Small Business Assistance
CDER, FDA
Wilsonr@cder.fda.gov

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