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  1. Industry (Biologics)

Manufacturers Assistance and Technical Training Branch (MATTB)

Email: Industry.Biologics@fda.hhs.gov
Phone: 240-402-8020 or 1-800-835-4709

After 4:30 pm EST weekdays, all day on weekends and federal holidays, all requests for expanded access for emergency use for drugs, biologics and medical devices should be directed to the FDA Emergency Call Center, telephone: 866-300-4374 or 301-796-8240.

 


 

What We Do
CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide timely, accurate and useful information to stakeholders.


How We Can Help You
If you have a question about a biologics topic, we may be able to help you. Our team makes every effort to respond to email within 5 business days. If we are unable to respond in this timeframe, we will contact you with an update or request for further clarification to better assist you.

If your inquiry is related to a regulatory submission that has been received by CBER, questions should be directed to the Regulatory Project Manager (RPM) assigned to that submission.


Mission
To provide our stakeholders with timely, accurate and useful information about CBER regulated products.


Vision
We strive to continuously educate our stakeholders with understandable and accessible science-based regulatory information about CBER regulated products. To achieve our mission, we stay current on regulatory issues, new scientific advances, and support CBER’s workforce to ensure that we disseminate information that is timely, accurate and useful.

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Manufacturers Assistance (CBER) Survey

 

MATTB Learn: Adobe presentations for industry

Services Provided to Industry

Key Resources

 

Additional Resources

Spotlight

 
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