FDA Circular on Stability Testing of Biotech Products

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FDA CIRCULAR NO. 2013-026: FDA Circular on Stability Testing of Biotech Products

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Title Source: Supreme Court: FDA Circular on Stability Testing of Biotech Products

Law: Fda Circular No. 2013-026

Decision Date: Nov 11, 2013

The FDA Circular No. 2013-026 mandates the adoption of the ICH Q5C guidelines for stability testing of biotechnological and biological products, ensuring their safety, efficacy, and quality in alignment with international standards.

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