CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process; Public Workshop October 15, 2009
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process.
- Agenda (PDF - 64KB)
- Registration form (PDF - 20KB)
- Meetings with FDA (PDF - 124KB), Judit Milstein, FDA
- FDA IRB & Informed Consent Regulations (PDF - 565KB), Kevin Prohaska, FDA
- Submitting an IND: What You Need to Know (PDF - 211KB), Maria Walsh, FDA
- A Primer for Understanding the Drug Development Process (PDF - 163KB), Robbin Nighswander, FDA
- Financial Assistance and Incentives for Research and Development of New Drug/Biologic Products (PDF - 124KB), Ron Wilson, FDA
Date: October 15, 2009
Time: 8:00 a.m. - 5:00 p.m.
Location: FDA's Center for Food Center for Food Safety and Applied Nutrition (CFSAN) at 5100 Paint Branch Parkway, College Park, MD 20740. Auditorium 1A003.
CFSAN is conveniently located across the street from the College Park Metrorail Station (see: Metro map ), which provides access to a large number of hotels in the Washington D.C. area. Parking is available.
Send the registration form to CDERSmallBusiness@fda.hhs.gov. For more information contact Ron Wilson at 301-796-3177 or Brenda Stodart at 301-796-3102.
There is no registration fee
Space is limited to 225 participants. We appreciate advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis.