FDA Posts Guidance on Safety-Related Labeling Changes for Drugs
A guidance is available on Food and Drug Administration-required safety labeling changes for some prescription drug and biological products (here). Under the 2007 Food and Drug Administration Amendments Act, FDA can require certain drug and biological product application holders to…
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make safety-related labeling changes based on newly-available safety information that becomes available after product approval. The authority does not apply for non-prescription drugs, said FDA.