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U.S. Department of Health and Human Services

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Small Pharmaceutical Business Educational Forum, Public Workshop, April 25, 2006

The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) in collaboration with the U.S. Small Business Administration is announcing a public workshop. The workshop is to provide information to small pharmaceutical businesses about FDA's premarket requirements; good manufacturing practices; OTC and generic drug issues; and the training, counseling, and contracting programs of the U.S. Small Business Administration.

Date and Time: April 25, 2006 from 8 a.m. to 5 p.m.

Location: U.S. Small Business Administration (SBA) at 409 Third Street, SW, Washington, D.C. 20416. The SBA is conveniently located next to the Federal Center SW station, on the Orange and Blue lines of the Washington, D.C. Metro System. It is near to the Capitol and the National Mall which is home to many federal agencies and the Smithsonian Museums. For directions to the SBA go to the following websites:

Lodging Accommodations: Since the location of the workshop is next to a metrorail station, a wide-range of accommodations are conveniently available in the Washington, D.C. area including the nearby Northern Virginia area.

Registration: Registration begins on March 15, 2006, and ends April 21, 2006. Registration is free. Seats are limited, please register early. Space will be filled in order of receipt of registration. Those registered will receive confirmation. Registration will close after available space fills. Registration at the site will be based on space availability on the day of the event starting at 8 a.m.

If you need special accommodations due to disability, please contact Ron Wilson at the contact information stated above at least 7 days in advance.

Registration Form Instructions: To register complete the following registration form and submit via:

  • Registration Form
  • Meeting Agenda
  •  Presentations
    • Mastering Regulatory Compliance, Thomas J. Arista, FDA [PDF]
    • Planning for Successful, Efficient, Pharmaceutical Product Development, Kim Colangelo, FDA [PDF]
    • FDA Assistance to Industry, Marie Falcone, FDA [PDF]
    • Introduction to SBA’S Business Loan Programs, SBA [PDF]
    • OTC Products, Susan Johnson, Ph.D., FDA [PDF]
    • U.S. Small Business Administration, Office of Entrepreneurial Development, SBA [PDF]
    • Generic Drugs, Ted Sherwood, FDA [PDF]
    • Small Business Funding Opportunities at NIH, Kathleen J. Shino, M.B.A. NIH [PDF]
    • Financial Assistance and Incentives for Research and Development of New Drug/Biologic Products, Ron Wilson, FDA [PDF]
       
  • Email: Ronald.Wilson@fda.hhs.gov
  • Fax: 301-827-3056, or
  • Mail to: Small Business Assistance, CDER, 5600 Fishers Lane, Room 12B45 Rockville, MD 20852-1750

Supplementary Information: The purpose of the public workshop is to provide small pharmaceutical businesses with firsthand knowledge of FDA's requirements and compliance policies for marketing drug products. Information will also be provided on current issues within the over- the counter (OTC), generic and new drug programs. The U.S. Small Business Administration will provide information on its financial, training, counseling, and contracting programs for small businesses. Topics to be discussed at the workshop include the following:

  • Using the programs of the U.S. Small Business Administration to help your business succeed
  • Planning for successful, efficient pharmaceutical product approval
  • Current challenges and concerns for generic abbreviated new drugs applications (ANDAs)
  • Regulatory aspects and challenges in the development of over- the-counter (OTC) drugs
  • Mastering regulatory compliance
  • Financial incentives and assistance provided by FDA and National Institutes of Health (NIH) for the development of new drug products
  • The Grant Program for Small Businesses at NIH

Ron Wilson
Director of Small Business Assistance
301-827-1694

SBA’s and FDA’s participation in this co-sponsorship is not an endorsement of the views, opinions, products or services of any co-sponsor or other person or entity. All SBA and FDA programs, services and co-sponsored activities are extended to the public on a nondiscriminatory basis. Reasonable arrangements for persons with disabilities will be made if requested at least two weeks in advance.  Contact: Ronald.Wilson@fda.hhs.gov Fax: 301-827-3056, or Mail to: Small Business Assistance, CDER, 5600 Fishers Lane, Room 12B45 Rockville, MD 20852-1750

  • Co-sponsorship Authorization number: 06-7320- 101