Ron Wilson, Director Small Business Assistance, Center for
Drug Evaluation and Research, 301-796-3177,
Business Guide to FDA. This guide provides information on how to obtain documents from
the FDA, instructional guides to the Federal Register, FDA contacts, and more.
Small Business Representatives. FDA has representatives who exclusively help
small businesses whose products are regulated by FDA. These individuals can provide
information that clarifies how agency laws and regulations apply to specific circumstances
and suggest methods of meeting those requirements. They can respond to inquiries, conduct
or participate in workshops and conferences, or visit your plant, at your request, to
U.S. Business Advisor.
Provides business with one-stop access to federal government information, services and
transactions to make the relationship between business and government more productive.
Inquiries. CDER contacts for requesting information on specific drugs, guidance
documents, publications, or general information such as a description of the drug approval
Directories. Includes the CDER Organization Chart with names and phone numbers,
Index to General Subjects, CDER Key Officials List, and other directories.
Getting in Touch with the
Right FDA Office.
The Center's ombudsman helps mediate disputes, plus provides feedback from inside and
outside the Center about the effectiveness of programs and about problems that impede
CDER's performance. The CDER ombudsman is: Warren Rumble, Phone -
301-594-5480, Fax -301-827-4312,
CDER Conferences and
Meetings. Information on upcoming conferences and workshops sponsored by CDER.
Calendar of Advisory Committee
Meetings & Other Meeting Notices. (updated weekly)
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FDA/Center for Drug Evaluation and Research
Last Updated: July 9, 2008
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