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Small Business Assistance

What's New for Small Pharmaceutical Businesses
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Although large corporations produce many of the products that FDA regulates, smaller businesses actually constitute a large majority of Center for Drug Evaluation and Research regulated companies. Such small businesses provide a vast array of the drug products available to American consumers.

Because FDA has long recognized the unique needs of small business, a network of FDA offices exists in the Commissioner's Office, in the regional offices, and in the product-specific Centers to help small businesses understand the Agency's structures and rules.  In the Commissioner's Office, the Office of Ombudsman has responsibility for liaison with the Small Business National Ombudsman for resolving complaints against the Agency brought by small business owners.  Also in the Commissioner's Office, the Economics Staff works with the Centers to assure that the impacts of all regulatory burdens on small businesses are considered, and that adverse impacts are lessened whenever possible, before regulations are issued.

In CDER, the Office of Training and Communication includes a small business staff that answers inquiries from small business owners, conducts outreach efforts, and participates in programs on emerging topics of interest to small business.

Each of FDA's five Regional Offices has a Small Business Representative (SBR) to provide outreach and training to, and answer specific inquiries from, small businesses across the country.  FDA Regional Offices have answered thousands of questions, conducted scores of training programs, and organized more than 50 "grassroots" meetings in the last few years to educate industry, particularly small business, about emerging regulatory topics of interest.  In addition, grassroots meetings are regularly conducted by the FDA Centers to elicit input on proposed regulations.

In addition to providing ready access to FDA personnel who are knowledgeable about the concerns of small business, FDA provides a wealth of written and electronic information of importance to small business.

In developing its regulatory policies and programs, FDA strives, whenever possible, to moderate adverse impacts on small business.  The Agency has received some 45 Vice-presidential "Hammer Awards" for regulatory improvements, virtually all of which directly benefit FDA's small regulated businesses. 

The purpose of this website is to assist small businesses with timely and accurate information on CDER's programs and services; organizational and contact information; and links to FDA laws, regulations and guidances that affect small business. Information is also provided on financial assistance and incentives that are available for drug development.  For helpful contacts within CDER or FDA, please see Consumer/Industry Inquiries.

To learn more about the drug review process, please see these free online training seminars.

We ask you to take time to communicate with CDER about this website.  What information is and isn't useful to you in understanding how to deal with the Center?  What additional items or categories of information would you like us to add?  Please use our comment form.

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Date updated: March 11, 2008

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