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General Information on Small Business Assistance
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 (CDER) regulated companies. Such small businesses provide a vast array of the drug products available to American consumers.
- What is a small business?
The definition of a small business used by the CDER Small Business Assistance Program is based on two statutes: Safe Medical Devices Act of 1990 and the Small Business Innovation Development Act of 1982. Both statutes specify that a small business is defined as having no more than 500 employees, including affiliates. An affiliate is defined as a business entity that has a relationship with a second business entity if one business entity controls, or has the power to control, the other business entity, or a third party controls, or has the power to control, both entities.
By definition, small businesses lack many of the resources available to larger pharmaceutical companies. In addition to having a limited number of employees, they are often engaged in the development of their first product. As such, they may have minimal to no experience with the laws and regulations governing drug development in the United States.
- How is CDER organized to help regulated small pharmaceutical businesses?
In CDER, the Office of Communications 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 meeting 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.
- What is the purpose of the Small Business Assistance website?
The purpose of this website is to assist small businesses with timely and accurate information on CDER's (Center for Drug Evaluation and Research) 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 small business inquiries, contact Brenda Stodart, Pharm.D. at 301-796-6707 or CDERSmallBusiness@fda.hhs.gov.
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