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U.S. Department of Health and Human Services


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CDER's Small Business Assistance Educational Forum: The Investigational New Drug (IND) Process; Public Workshop October 8, 2010

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 (IND) Process and key aspects related to rare disease drug development and clinical trials.



Date, Time and Location

The meeting will be held on October 8, 2010, beginning at 9:15 a.m., at the following location:

National Labor College (NLC)
George Meany Campus
10,000 New Hampshire Ave.,
Silver Spring, Maryland 20903
(301) 431-6400
The meeting will not be videotaped or webcast.

Free parking is provided. Free wireless access on campus. Lunch will not be provided but there is a cafeteria on premises and several fast food options within walking distance.

Sleeping accommodations are available through NLC and nearby hotels. *




Metro Rail Directions

Travelers from Reagan National Airport have the option of using the DC area’s Metro Rail System (see the Metro System Map). Please refer to the Washington Metropolitan Area Transit Authority's website for public transportation information: www.wmata.com

The closest Metro Rail station is Silver Spring (http://www.wmata.com/metrorail/Stations/station.cfm?station=31) which is on the Red Line. Metro station is approximately 8 miles from White Oak Campus. From National Airport, riders may take the Blue Line to the Red Line (transfer at Metro Center) or the Yellow Line to the Red Line (transfer at Gallery Place). From the Silver Spring Station, take taxi to the building or see information below for “Ride-On Bus” (operated by Montgomery County).


Ride-On Bus

Ride-On bus route 22 operates between the Silver Spring Metro Station and White Oak Campus: http://www.montgomerycountymd.gov/tsvtmpl.asp?url=/content/dot/transit/routesandschedules/allroutes/route022.asp


Nearby Hotels

Hilton Washington DC/ Silver Spring
8727 Colesville Road
Silver Spring , MD 20910
Phone: 301-589-5200

Silver Spring Courtyard North (Marriott)
12521 Prosperity Drive
Silver Spring , MD 20904
Phone: 301-680-8500

Silver Spring Residence Inn (Marriott)
12000 Plum Orchard Drive
Silver Spring , MD 20904
Phone: 301-572-2322



There is no registration fee.


Space is limited to 150 participants. We appreciate advance notice of cancellations or replacements. Participants will receive confirmation of registration.

* Fees for accomodations are not included as part of the registration.

If you require special accommodations due to a disability, please contact CDR Brenda Stodart at 301-796-3400, at CDERSmallBusiness@fda.hhs.gov at least 7 days in advance of the meeting.




Meeting Agenda (PDF - 42KB)

The Investigational New Drug (IND) application process is a crucial step in the drug development and approval process.  The objective of this workshop is to clarify and explore fundamental aspects of the IND. 

Highlights include:
  • Drug Development timeline
  • Phases of an IND
  • Types of Meetings with FDA
  • Clinical Development of rare diseases
  • Examples of recent rare disease programs
  • Rare disease help and information at FDA
  • Goals of Inspections: Clinical Investigator Program
  • Selecting Clinical Investigators for Audit
  • FDA Expectations of Clinical Investigators
  • Inspectional Procedures/DSI Actions


Presentation slides

Handouts will not be printed and available at the conference. Presentations will be added to the website and announced to participants as they become available for printing.


Contact Us

For further information about this meeting, contact:

CDR Brenda Stodart
e-mail: CDERSmallBusiness@fda.hhs.gov