FDA NOTE TO CORRESPONDENTS
For Immediate Release: May 3, 2012
Consumer Inquiries: 888-INFO-FDA
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:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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