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.
To provide our stakeholders with timely, accurate and useful information about CBER regulated products.
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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MATTB Learn: Adobe presentations for industry
Services Provided to Industry
- Receive, track, and process CBER's Speaker Requests
- Receive requests for Expanded Access to investigational biologics
- Coordination of CBER's Liaison Meetings with Industry (PDF - 127KB)
- Coordination of CBER's Regulatory Site Visit Training Program (RSVP) (PDF - 47KB)
- What does FDA regulate?
- Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER Regulates
- Industry Frequently Asked Questions
- Webinars and Outreach
- Biologics Establishment Registration
- Biological Product Deviations
- Clinical Investigator Information
- Master Files for CBER-Regulated Products
- Advertising & Promotional Labeling Questions and Answers
- CBER Product Jurisdiction
- Transfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER)
- Intercenter Agreement Between the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health
- FDA's Office of Regulatory Affairs (ORA)
- Device Advice: Comprehensive Regulatory Assistance
- Zika Virus Response Updates from FDA
- Center for Disease Control (CDC)
- Clinical Laboratory Improvement Amendments (CLIA)
- Contact Health Resources & Services Administration (HRSA)