Vaccines, Blood & Biologics
Resources for You
Industry (Biologics)
The Center for Biologics Evaluation and Research (CBER) has established a Manufacturers Assistance and Technical Training 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.
Laws, Regulations, Guidances and Other Information
Establishment Registration
Product Development
Product Application and Approval
Postmarketing, Compliance and Enforcement
- Biologics Post-Market Activities
- Biologic Product Security
- Biologic Product Shortages
- Compliance Programs (CBER)
- Impact of Severe Weather Conditions on Biological Products
- Importing & Exporting (Biologics)
- Lot Distribution Database (LDD)
- Product Surveillance (CBER)
- Recalls (Biologics)
- Report a Problem to the Center for Biologics Evaluation & Research
- Direct Recall Classification Program (Blood and Plasma)
- Safety & Availability (Biologics)
- Untitled Letters (CBER)
Recalls & Alerts
Contact Us
- (800) 835-4709
- (301) 827-1800
- matt@fda.hhs.gov
Manufacturers Assistance and Technical Training Branch (CBER)
Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-41
Rockville, MD 20852-1448