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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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
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Related Book For
Pharmacy Practice And The Law
ISBN: 9781284154979
9th Edition
Authors: Richard R. Abood, Kimberly A. Burns
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