BFAD Circular on Labeling of COX-2 Inhibitors and NSAIDs

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Title Supreme Court: BFAD Circular on Labeling of COX-2 Inhibitors and NSAIDs

Law: Bfad Bureau Circular No. 11, S. 2005

Decision Date: Jun 7, 2005

BFAD mandates revised labeling for selective COX-2 inhibitors and NSAIDs, requiring boxed warnings about cardiovascular and gastrointestinal risks, while emphasizing the importance of using the lowest effective dose for the shortest duration.

administrative law

drug regulation

pharmaceutical law

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