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  1. Development & Approval Process (Drugs)

About CDER Small Business and Industry Assistance (SBIA)

About CDER Small Business and Industry Assistance (SBIA)

What We Do

CDER Small Business and Industry Assistance (SBIA), is often the first stop for a small pharmaceutical business trying to contact the Agency. Our goal is to help small pharmaceutical business and industry navigate the wealth of information that FDA offers, and to provide assistance in understanding the regulation of human drug products. Some of our outreach services include:

  • Direct communication services  We respond to industry inquiries via phone and email
  • Webinars:  We offer frequent and timely webinars on various topics of interest to industry.
  • Conferences and Workshops:  We host several conferences each year, including Spring and Fall Regulatory Education for Industry (REdI)) conferences, and topic-specific REdI Conferences. Many of these conferences are available for attendance in-person or virtually.
  • CDERLearn:  We offer web-based learning tutorials on the CDER Small Business and Industry Education Series platform. This is part of a larger platform, CDERLearn, which contains educational tutorials offered by all of CDER.
  • Small Biz Buzz:  We send email updates on a regular basis to educate industry on new regulations, guidances, and meetings.
  • CDER Small Business Chronicles:  We publish this electronic newsletter every other month, highlighting various regulatory issues.

Mission and Vision Statement

CDER SBIA’s mission is to engage with small pharmaceutical business and industry by providing timely and accurate information on human drug development and regulation

Our vision is to ensure that every industry representative can always find the resources they need, allowing for a clear and efficient approval process and safe and effective human drugs options.

Who We Serve

Though focused on small business, CDER SBIA serves all of the regulated pharmaceutical industry, both domestically and internationally. We interact with industry in several ways and strive to provide timely and accurate information relating to the development and regulation of human drug products.

What is a Small Business?

For CDER SBIA purposes, the term “small business” is defined as a business that has fewer than 500 employees, including employees of affiliates. An affiliate is further 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.

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