SafetyCall International, LLC
3600 American Boulevard W, Suite 725
Bloomington, MN 55431
Highlights – Rules & Regulations

Several important regulations applicable to the Pharmaceutical Industry are highlighted below:

  • Section 3 – Adverse events meeting the FDA defined criteria for serious must be reported to the FDA within 15-days using the FDA Form 3500A and its accompanying data elements.
  • Causality is not a prerequisite for tracking and reporting adverse events involving prescription drugs distributed in the USA.
Your Industry Obligations

Pharmaceutical registrants must also consider the following compliance obligations:

  • 21 CFR 310.305 and 21 CFR 314.80
  • Food and Drug Act