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FDA issued a final rule on sterility testing on May 3 which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.
FDA issued a final rule on sterility testing on May 3, 2012, that amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. The rule is in response to President Obama’s Executive Order 13563 which called for improving regulation and regulatory review.
Specifically, the rule revises sterility requirements under Title 21 of the Code of Federal Regulations (CFR), subchapter F, parts 600 through 680 as follows:
Companies will not have long to implement the changes as the rule takes effect June 4, 2012. The proposed rule received several comments from industry and the final rule includes the agency’s response to those recommendations. Overall, FDA “recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner,” according to an FDA announcement of the rule. “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.”