FDA Releases Guidance on Toll-Free Numbers on Drug Labels
The Food and Drug Administration announced the availability of a guidance intended to help small businesses understand and comply with the requirements of the final rule regarding labeling of drugs with a toll-free number for adverse event reporting, published in…
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the Federal Register on October 28, 2008. The guidance entitled “Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications; Small Entity Compliance Guide,” which FDA says describes certain requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule, is available here.