The FDA’s Center for Biologics Evaluation and Research (CBER) is the division of the agency that “regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.” With everyone from traditional pharmaceutical companies to start-up ventures realizing the promise of large-molecule (biologic) therapies, an understanding of the regulations is critical to successfully developing a biologic and getting your product to market. While many of the regulations are similar to those that govern traditional small-molecule pharmaceuticals, there are significant differences which must be understood for your efforts to be successful.
This 90-minute webinar will provide you with a foundational understanding of biologics regulations. By attending, you will learn:
- CBER vs. CDER: Learn the major regulatory differences
- Simplifying FDA’s regulatory landscape for biologics: What do the latest guidances mean?
- Biologics development: What steps can you take to ensure successful regulatory submissions?
- What the future holds: Looking ahead at the regulatory horizon