FDA Releases Adverse Event Guidance for Small Businesses

The US Food and Drug Administration (FDA) wants to help small businesses comply with regulations pertaining to adverse event reporting.

In 2008, the agency released a new regulation directing all companies to include a hotline number for FDA's adverse event reporting service, which collects information about safety issues. The number must coincide with an explanation of what the number is, and that it is not intended for dispensing medical advice.

In its 14 June guidance, Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications: Small Entity Compliance Guide, provided an outline for the circumstances under which a product would be required to place the number on or along with its packaging.

The hotline number must be included on all medication guides and with each product dispensed if the product was approved under Section 505 of the Federal Food, Drug and Cosmetic Act (FD&C Act). A limited number of other products approved under Section 505 must also contain the hotline number in the product's labeling.

While further guidance followed the 2008 regulation (Medication Guides-Adding a Toll-Free Number for Reporting Adverse Events), FDA's new guidance is what's known as a level 2 guidance-guidance to assist sponsors with guidance in even further detail by clarifying minor points.

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