FDA Circular on Post-Approval Pharma Changes

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FDA CIRCULAR NO. 2014-008: FDA Circular on Post-Approval Pharma Changes

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Title Source: Supreme Court: FDA Circular on Post-Approval Pharma Changes

Law: Fda Circular No. 2014-008

Decision Date: Apr 1, 2014

FDA Circular No. 2014-008 establishes a comprehensive application process and requirements for Marketing Authorization Holders to implement post-approval changes to registered pharmaceutical products, incorporating ASEAN guidelines and country-specific regulations to ensure product safety, efficacy, and quality.

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