The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), 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 programs of the Small Business Administration and the National Institute of Standards and Technology that assist small businesses.
- Date and Time: The public workshop will be held on April 25, 2007 from 8:00 a.m. to 5:00 p.m.
- Agenda [PDF]
- 2007 Small Business Pharmaceutical Workshop [PDF], Patricia L. Adcock, FDA
- Planning for Successful, Efficient, Pharmaceutical Product Development [PDF], Kim Colangelo, FDA
- FDA Assistance to Industry [PDF], Marie Falcone, FDA
- OTC Products [PDF], Susan Johnson, FDA
- Generic Drugs [PDF], Ted Sherwood, FDA
- Manufacturing Extension Partnership (MEP) [PDF], Paul Vinikoor, Potomac Region of the Maryland Technology Extension
- Financial Assistance and Incentives for Research and Development of New Drug/Biologic Products [PDF], Ron Wilson, FDA
Additional 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 with the-over-counter (OTC), generic and new drug programs. The U.S. Small Business Administration and the National Institute of Science and Technology will provide information on their programs for helping small businesses succeed. Topics to be discussed at the workshop include the following:
- 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
- FDA's Small Business Assistance Program
- Using the programs of the U.S. Small Business Administration the National Institute of Standards and Technology to help your business succeed
Contact: Ron Wilson
Director of Small Business Assistance
SBA’s and FDA’s participation in this cosponsorship is not an endorsement of the views, opinions, products or services of any cosponsor or other person or entity. All SBA and FDA programs, services and cosponsored 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. Cosp. Auth. No. 07-7630-07.