Industry (Biologics)
CBER’s Policies, Procedures, and Review Resources
This webpage serves industry professionals, providing them with important information and resources related to the regulatory framework of products regulated by CBER, including guidances, policies, procedures, and other available review resources.
The U.S. Food and Drug Administration (FDA) is a regulatory authority that has oversight of the safety, effectiveness, and quality of medical products that are approved and distributed for use in the United States.
CBER regulates biological products for human use under applicable federal laws, including the Public Health Service Act (PHS Act) and the Federal Food, Drug, and Cosmetic Act (FD&C Act), ensuring that products are of high quality, they are safe and effective for their intended use, and the labeling is informative, accurate, and not misleading.
CBER reviews applications for new products and approved products seeking a new indication, new active ingredient, new patient population, new dosage form, and new dosing regimen. The application review requires evaluating submitted scientific and clinical data to determine whether the product meets rigorous standards for approval. After a thorough assessment of the data, CBER decides based on the risk-benefit evaluation whether the product can be approved and marketed in the United States for use in the intended population, ensuring that the safety, efficacy, and consistent manufacturing quality were adequately demonstrated.
CBER offers dialogue, regulatory expertise, and provides comprehensive tools to the inventors and developers of new products. To find more information on how to interact with CBER, visit Formal Meetings and Requests for Feedback for CBER-Regulated Products website.
- FDA Guidances
- Biologics Guidances
- Application Submissions Guidances
- Meeting Guidances:
- Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
- SOPP 8101.1 - Appendix C: PDUFA Meeting Information
- Draft Guidance for Industry: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff
- Draft Guidance for Industry: Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications
- Biologics Procedures (SOPPs)
- FDA Rules and Regulations
- Biologics Rules
- 21 CFR 600-680 (General Biologics Regulations): Comprehensive regulations governing biologics, including licensing requirements
- Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Federal Register (FR) Notices
- Dockets Management
- Biosimilar User Fee Amendments (BsUFA)
- 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
- Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions
- Phase 1 Investigational New Drug (IND) Navigator
- FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development
- Investigational New Drug Applications (INDs) for CBER-Regulated Products
- Frequently Asked Questions about Minimally Manipulated, Unrelated Cord Blood Products for Clinical Use
- Expanded Access to Experimental Biologics
- Coronavirus (COVID-19) | CBER-Regulated Biologics
- CBER Rare Disease Program
- Clinical Trials and Human Subject Protection
- ClinicalTrials.gov
- Animal Rule Information
- Biologics License Applications (BLAs) for CBER-Related Products
- Premarket Approval (PMA) for CBER-Regulated Products
- New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products
- Premarket Notification 510(k) Process for CBER-Regulated Products
- 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 System (UDI System)
- Formal Meetings and Requests for Feedback: CBER-Regulated Products
- Master Files for CBER-Regulated Products
- Labeling for CBER-Regulated Products
- FDA Labeling Resources for Human Prescription Drugs
- Biosimilars
- Biologics Products & Establishments
- Other Recommendations for Biologics Manufacturers
- Guidance, Compliance & Regulatory Information (Biologics)
- About FDA
- What does FDA regulate?
- Industry Frequently Asked Questions
- Educational Resources
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The latest information from the Center for Biologics Evaluation and Research.