A manufacturer learns postmarket that its drug is increasingly being linked to an adverse effect not apparent

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A manufacturer learns postmarket that its drug is increasingly being linked to an adverse effect not apparent during the IND process. Explain the process required if the manufacturer decides it wants to include a warning in its labeling.

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Pharmacy Practice And The Law

ISBN: 9781284154979

9th Edition

Authors: Richard R. Abood, Kimberly A. Burns

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Question Posted: Feb 28, 2024 04:01 AM

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A manufacturer learns postmarket that its drug is increasingly being linked to an adverse effect not apparent

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Process for Including a Warning in Drug Labeling When a manufacturer discovers that its drug is increasingly associated with an adverse effect postmar...View the full answer

Pharmacy Practice And The Law

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