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 In this section:

                Industry (Biologics)

Industry (Biologics)

                        CBER Advanced Technologies Program
          Manufacturers Assistance and Technical Training Branch (MATTB)


                        Coronavirus (COVID-19) | CBER-Regulated Biologics Home
          Vaccines, Blood & Biologics
          Resources for You (Biologics)
          Industry (Biologics)
          Manufacturers Assistance and Technical Training Branch (MATTB)Industry (Biologics) Manufacturers Assistance and Technical Training Branch (MATTB)
  
  	
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    Print**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.

**Help us improve our Manufacturers Assistance (CBER) web page!**Manufacturers Assistance (CBER) Survey

Guidance

Recently Issued Guidance Documents

Clinical Trials Guidance Documents

CMC and GMP Guidances

Combination Products Guidance Documents

Electronic Submissions

For assistance with electronic submissions, contact CBER ESUB at esubprep@fda.hhs.gov

Electronic Common Technical Document (eCTD)

Electronic Submissions Gateway

FDA eSubmitter

Importing and Exporting CBER-Regulated Products

CBER Regulated Products

Importing CBER-Regulated Products into the United States

Exporting CBER-Regulated Products



MATTB Learn: Adobe presentations for industry

Requesting Speakers from FDA/CBERServices 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)Key Resources

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
	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) - Archived
	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)

Additional Resources

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)Spotlight

Workshops, Meetings & Conferences (Biologics)
	Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
	Expanded Access (sometimes called "Compassionate Use")

                                                                                  Content current as of:
      02/17/2023Industry (Biologics)

          
                        CBER Advanced Technologies Program
          Manufacturers Assistance and Technical Training Branch (MATTB)


                        Coronavirus (COVID-19) | CBER-Regulated Biologics
 
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