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 February 13, 2023, due to the initially limited availability of upgraded conference rooms, CDER and CBER will restart in-person FTF Industry meetings (with a hybrid component,) starting with Type A, BPD 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 meetings received or scheduled before February 13, 2023, 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 [email protected].
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
- Memoranda to Blood Establishments
- 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
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
- Clinical Investigator Information
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