Industry (Biologics)
CBER’s Policies, Procedures, and Review Resources
This webpage provides important resources related to the regulatory framework of products regulated by CBER, including policies, procedures, and review resources.
CBER reviews applications for new products, new indications for already approved products, and product-related changes. This requires evaluating submitted scientific and clinical data to determine whether the product meets CBER's standards for approval. After a thorough assessment of the data, CBER makes a decision based on the risk-benefit for the intended population and the product's intended use. CBER's authority resides in the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act.
Beginning June 12, 2023, CDER and CBER will expand in-person FTF industry meetings (with a hybrid component), to include requests for Type B End-of-Phase 2 (EOP2), along with the previously announced Type A, BPD Type 1, and Type X meeting requests. FTF meeting requests for other meeting types, if granted, will be held fully virtually (i.e., the in-person format will not be considered). Existing meeting requests received before June 12, 2023, or meetings already scheduled regardless of the scheduled meeting date, will not be converted to the in-person format, to permit fair implementation of the transition. For more information, please visit Update on In-Person Face-to-Face Formal Meetings with FDA. For general questions, please contact industry.biologics@fda.hhs.gov.
For detailed information on how to request a meeting with CBER and to find guidance on meeting request content, please visit Formal Meetings for CBER-Regulated Products | FDA.
Laws, Regulations, Guidances and Other Information
- Biologics Guidances
- Biologics Procedures (SOPPs)
- Biologics Rules
- FDA Rules and Regulations
- Biosimilars
- Dockets Management
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Federal Register (FR) Notices
- Generic Drug User Fee Amendments
- Biosimilar User Fee Amendments
- Medical Device User Fee amendments (MDUFA)
- Prescription Drug User Fee Act (PDUFA)
- Food and Drug Administration Safety and Innovation Act (FDASIA)
- 21st Century Cures Act
- The Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions
Establishment Registration
Product Development
- Frequently Asked Questions about Minimally Manipulated, Unrelated Cord Blood Products for Clinical Use
- Investigational New Drug Applications (INDs) for CBER-Regulated Products
Product Application and Approval
- Biologics License Applications (BLA) Process (CBER)
- Premarket Approval (PMA) for CBER-Regulated Products
- New Drug Application (NDA) Process (CBER)
- Premarket Notification 510(k) Process for CBER-Regulated Products
- Advertising & Labeling (Biologics)
- U.S. Food and Drug Administration Statement: The impact of February’s inclement weather on Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) deadlines
Postmarketing, Compliance and Enforcement
- Biologics Post-Market Activities
- Biologic Product Security
- CBER-Regulated Products: Shortages and Discontinuations
- Compliance Programs (CBER)
- Impact of Severe Weather Conditions on Biological Products
- Exporting CBER-Regulated Products
- Lot Distribution Database (LDD)
- Product Surveillance (CBER)
- Recalls (Biologics)
- Report a Problem to the Center for Biologics Evaluation & Research
- Direct Recall Classification Program
- Safety & Availability (Biologics)
- Untitled Letters (CBER)
- Unique Device Identification - UDI
More Information
Follow CBER
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
For Updates on Twitter, follow @fdacber