Pharma Company Receives Safety Warning Letter
The FDA recently published a Warning Letter to a pharmaceutical company citing its “failure to develop adequate written procedures for surveillance, receipt, evaluation and reporting of post-marketing adverse drug experiences (ADE) to FDA.”
All New Drug Application (NDA) holders are required to have written procedures to detect, correctly identify, assess and report ADEs to the FDA. One of the failures to do so in this case was linked to a lack of communication between business partners.
DDN Medical Affairs has extensive experience in communicating with multiple partners on behalf of our clients to provide compliance with the regulations and mandatory timelines for AE reporting.
Contact Us to learn more about ways in which DDN Medical Affairs can partner with you to meet your regulatory obligations.