Amendment on Adverse Drug Reaction Reports

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FDA CIRCULAR NO. 2010-009: Amendment on Adverse Drug Reaction Reports

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Title Supreme Court: Amendment on Adverse Drug Reaction Reports

Law: Fda Circular No. 2010-009

Decision Date: Apr 16, 2010

The FDA mandates that serious adverse drug reaction reports must be submitted within 72 hours and no later than 7 working days, while other adverse reactions are to be reported quarterly, ensuring timely monitoring of pharmaceutical safety.

adverse drug

reaction

administrative law

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