U.S. FDA Adverse Event Contact Requirement for OTC Drugs
U.S. FDA requires labels of OTC drugs marketed without an approved application to bear a United States address or phone number to receive consumer reports of A serious adverse event is a health related event associated with the use of a drug that results in or requires medical intervention to prevent death or other serious injury.serious adverse events.
Registrar Corp can serve as your U.S. Contact for the timely forwarding of consumer reports to your business as required by FDA. For more information, simply complete the form below.