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  1. CDER Small Business & Industry Assistance (SBIA)

About CDER Small Business and Industry Assistance (SBIA)

What We Do

CDER 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 assist in understanding human drug product regulation. To do this, SBIA provides:

  • Direct communication services: Service to respond to inquiries from industry stakeholders via phone and email.
  • Webpages:
    • SBIA Landing Page: A comprehensive webpage to guide stakeholders to important regulatory information and training resources.
    • Regulatory References:  A repository of information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more.
  • Training Resources:
  • News and updates:
    • Industry News: Email updates to educate industry on new regulations, guidances and meetings.
    • SBIA on LinkedIn: A method to receive regulatory updates and event notifications via LinkedIn.
    • CDER Small Business Chronicles: An electronic newsletter and audio podcast highlighting various regulatory issues.

Mission and Vision Statement

Vision: To serve as the premier educational source on human drug and biopharmaceutical development and regulation.

Mission: To ensure that industry stakeholders have immediate access to resources, education and training allowing for a more clearly informed and efficient developmental process, with the goal of approving safe and effective human drugs and biopharmaceuticals.

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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