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Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
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CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
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Industry

Action Plans

Adverse Event Reporting

Clin Investigator Info

Combination Products

Counterfeit Initiative

Device Applications

Electronic Submissions

Export Certification

FAQs

FDAMA

How to Submit an IND

MDUFMA

PDMA

PDUFA

Product Shortages

Postmarket Commitments

Publications

Related References

Small Business

SOPPs

 

The Center for Biologics Evaluation and Research (CBER) has established a manufacturers assistance program to provide assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures.

Manufacturers assistance is available in numerous areas including: clinical investigator information, adverse event reporting procedures, electronic submissions guidance and requirements, and information on how to submit an investigational new drug application to administer an investigational product to humans. This assistance extends to facilitating effective development of all products regulated by CBER including products to diagnose, treat or prevent outbreaks from exposure to the pathogens that have been identified as bioterrorist agents.

The Manufacturers Assistance and Technical Training Branch (MATTB) informs industry and trade associations of the status of CBER policies and initiatives through regular information dissemination and training. MATTB also serves as the CBER focal point for industry and trade associations to provide meeting support, and coordinates external meetings with other FDA Centers.

If you have questions or are unable to find the information you need, please contact:

Center for Biologics Evaluation and Research
Office of Communication, Training & Manufacturers Assistance
Manufacturers Assistance and Technical Training Branch
800-835-4709 or 301-827-1800
matt@cber.fda.gov

 

FEDERAL REGISTER Regulatory Site Visit Training Program - 9/23/2004 - (PDF), (Text)

 

Impact of Severe Weather Conditions on Biological Products

 

Transfer of Therapeutic Products to CDER

 
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