Contact, Organization, and Meeting Information

Small Business Assistance

• Brenda Stodart, Pharm.D., Center for Drug Evaluation and Research, 301-796-6707, CDERSmallBusiness@fda.hhs.gov.

• Small 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 Contacts.  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 offer assistance.

• 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.

• CDER Personnel Directories.  Includes the CDER Organization Chart with names and phone numbers, Index to General Subjects, CDER Key Officials List, and other directories.

• CDER Ombudsman.  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: Virginia Behr, Phone - (301) 796-3436, Fax - (301) 847-8752, cderombudsman@fda.hhs.gov.

• CDER Conferences and Meetings.  Information on upcoming conferences and workshops sponsored by CDER.

• Calendar of Advisory Committee Meetings & Other Meeting Notices (updated weekly)