Effective December 22, 2007 manufacturers, packers or distributors of OTC drugs and dietary supplements must submit any serious adverse event to the U.S. Food and Drug Administration (FDA) within 15 business days of learning of it. All dietary supplement companies need to have a process in place to handle adverse event reporting (AER).

We help companies develop AER reporting and record keeping procedures to comply with the new laws and FDA regulations.

Does your company have a process in place and a trained staff to manage AER reporting?