FDA amends requirements for most licensed biological products

FDA issues final rule on sterility testing of biological products

Provides greater flexibility for development of sterility test methods 

The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products. The action follows a retrospective review of agency regulations to promote improvement and innovation and is in response to Executive Order 13563 that is designed to improve regulation and regulatory review. The FDA recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner. This action reflects the agency's efforts to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science. The amendments to the sterility testing rule will provide manufacturers of biological products the flexibility, as appropriate, to keep pace with technological and scientific advances. For more information: 

• Sterility Testing Final Rule for Biological Products
• Focus on Innovation
• Advancing Regulatory Science 
• Enabling Innovation for Biological Product Safety