120 day Safety Update Report

 Any new safety information regarding the drug that could reasonably influence the statement of contraindications, warnings, precautions, and adverse reactions in the proposed drug labeling is included in the 120 Day Safety Update.
The report, which is alternatively referred to as the Safety Update Report, is required to be submitted to the FDA for review within 120 days subsequent to the submission of the drug application (NDA), which includes the CTD/Integrated Summary Report.
Trilogy, being a leading provider of clinical regulatory documentation across various domains, possesses the necessary capabilities to offer comprehensive assistance to our clients concerning all aspects of PV documentation. This includes constructing Periodic Adverse Drug Experience Reports (PADERs) and Development Safety Update Reports (DSURs).