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10001 New Hampshire Ave, Silver Spring, MD 20903-1707, USA

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FDA CDER Small Business and Industry Assistance (SBIA)

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Guiding Your Pharmaceutical Success Through FDA Expertise and Support

The organization operates as a dedicated division within the U.S. Food and Drug Administration, focusing on providing support and resources to small businesses and the pharmaceutical industry. It serves as an essential conduit for navigating the complex landscape of drug regulation, offering guidance on FDA-approved drugs, including their regulatory history, usage, and compliance requirements. By extending comprehensive assistance in the realm of human drug products, the entity ensures stakeholders have access to accurate, timely information necessary for successful market participation.

Additionally, the organization stands as a crucial first point of contact for emerging businesses in the pharmaceutical sector, fostering a clear understanding of FDA procedures and drug product regulations. It aims to demystify the regulatory process by offering detailed insights into product approvals, safety information updates, and changes in federal requirements. By facilitating effective communication between regulatory bodies and the industry, the entity plays a pivotal role in promoting informed decision-making and sustainable business growth within the pharmaceutical landscape.

Guiding Your Pharmaceutical Success Through FDA Expertise and Support

The organization operates as a dedicated division within the U.S. Food and Drug Administration, focusing on providing support and resources to small businesses and the pharmaceutical industry. It serves as an essential conduit for navigating the complex landscape of drug regulation, offering guidance on FDA-approved drugs, including their regulatory history, usage, and compliance requirements. By extending comprehensive assistance in the realm of human drug products, the entity ensures stakeholders have access to accurate, timely information necessary for successful market participation.

Additionally, the organization stands as a crucial first point of contact for emerging businesses in the pharmaceutical sector, fostering a clear understanding of FDA procedures and drug product regulations. It aims to demystify the regulatory process by offering detailed insights into product approvals, safety information updates, and changes in federal requirements. By facilitating effective communication between regulatory bodies and the industry, the entity plays a pivotal role in promoting informed decision-making and sustainable business growth within the pharmaceutical landscape.

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Silver Spring Location

10001 New Hampshire Ave, Silver Spring, MD 20903-1707, USA