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CAPT Brenda Stodart, PharmD, FDA Small Business and Industry Assistance Program Director
FDA's Brenda Stodart outlines the services of the Agency's Small Business and Industry Assistance (SBIA) Program.
Taking a drug product from proof of concept to the consumer’s medicine cabinet is a worthwhile and complex path for any pharmaceutical manufacturer. Within the rubric of complexity small businesses must overcome numerous challenges -- many due to a lack of resources available to larger pharmaceutical companies. By definition, small businesses have fewer than 500 employees and are often engaged in the development of a single innovative product so it’s no surprise that many small companies have limited experience with navigating U.S. laws and regulations governing drug development.
To help small businesses succeed in bringing safe and effective drug products to market, the Food and Drug Administration (FDA) offers a Small Business and Industry Assistance (SBIA) Program. Under FDA’s Center for Drug Evaluation and Research (CDER), the SBIA Program provides regulatory information, real-time access to staff and a variety of educational conferences, workshops and webinars.
The path to drug development
It takes a great deal of time and persistence to engage in the drug development process and obtain FDA approval to market a drug product in the United States. Even after drug approval, regulatory vigilance and monitoring by drug product sponsors and the FDA remain necessary to ensure that consumers continue to receive the same high quality product. CDER’s SBIA Program provides a sound starting point for any pharmaceutical company embarking on a drug development path. CDER SBIA personnel assist companies by helping them navigate the regulatory process, providing assistance with understanding available guidances and regulations, and by providing timely information as regulations evolve.
Helping small pharmaceutical companies navigate and learn
The CDER SBIA Program produces free in-person and simulcast education conferences. The Program also creates educational webinars and in-depth online courses on various technical aspects of drug development. In addition, it provides informational updates through the CDER website, through timely e-blasts to more than 90,000 email recipients and through responses to thousands of individual requests for information answered by FDA personnel knowledgeable about the concerns of small businesses. Service highlights include the following.
Each year CDER SBIA hosts two “Regulatory Education for Industry (REdI)” Conferences in collaboration with the Center for Devices Evaluation and Research (CDRH) and two topic-specific REdI Conferences. Most conferences can be attended either in-person or virtually. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ ucm485853.htm
CDER SBIA offers frequent and timely webinars on various topics of interest to industry. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm
Web-based learning tutorials are placed on the CDER Small Business and Industry Education Series platform. This is part of a larger platform, CDERLearn, which also contains the educational tutorials offered by all of CDER. http://www.fda.gov/Drugs/Development ApprovalProcess/SmallBusinessAssistance/ucm483822.htm.
The CDER SBIA webpage - www.fda.gov/cdersbia - offers an entry platform customized to the needs of small pharmaceutical entities. This website contains a wealth of information regarding development and other considerations for marketing drug products. Those seeking information online can also go to the CDER SBIA LinkedIn Showcase page at: https://www.linkedin.com/company/cder-small-business-and-industry-assistance.
CDER SBIA Publications/Communications:
Small Biz Buzz: Regular email updates to educate industry about new regulations, guidances, and meetings.
SBIA Chronicles: Electronic newsletter that highlights a specific regulatory issue every other month.
Direct Communication Services:
CDER SBIA provides dedicated telephone numbers and an email address for industry to make direct contact. We respond to thousands of emails and phone calls each year.
Helping abroad: interaction with foreign regulators
In addition to its domestic small business support, CDER SBIA works with the Office on International Programs and Office of Regional and Country Affairs to meet and collaborate with foreign regulators to exchange ideas and improve communication efforts.
It’s noteworthy that many small pharmaceutical businesses are bringing innovative medical products to the U.S. marketplace. Indeed, small businesses are big contributors to the U.S. health and economy. Since 2010, the CDER SBIA program has provided regulatory navigation assistance and education to thousands of people in the small business arena.
For more about FDA’s CDER SBIA Program and services visit: www.fda.gov/cdersbia and https://www.linkedin.com/company/cder-small-business-and-industry-assistance.
Brenda Stodart is a Captain in the United States Public Health Service and Program Director of the Small Business and Industry Assistance Program within the FDA Center for Drug Evaluation and Research.