120 Day Safety Update (also referred to as 4 Month Safety Update, 4MSU)

  • The 120 Day Safety Update contains any new safety information learned about the drug that may reasonably affect the statement of contraindications, warnings, precautions, and adverser reactions in the draft drug labelling.
  • Also know as the Safety Update Report, the report must be received by the FDA within 120 days of drug approval submission (receipt by the FDA of the New Drug Application (NDA), comprising the CTD/Integrated Summary Report).
  • As a major provider of all types of clinical regulatory documentation, Trilogy is well placed to support our clients in all elements of PV documentation, including Development Safety Update Reports (DSURs) and Periodic Adverse Drug Experience Reports (PADERs).
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