The Center for Biologics Evaluation and Research (CBER) has established a Manufacturers Assistance Branch 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 (IND) to administer an investigational product to humans.

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
Division of Manufacturers Assistance and Training
Manufacturers Assistance and Technical Training Branch
800-835-4709 or 301-827-1800

*Please choose one method of contacting us.

CBER is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. Submit a written or electronic request for participation in this program by February 21, 2008. See the Federal Register Notice "Regulatory Site Visit Training Program" for further information.

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Action Plans

Acts & Regulations

Compliance and Surveillance

Guidances, Rules, and Standard Operating Procedures

Import & Export

Product Development and Application Submission

Updated: July 10, 2008