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20 april 2023
Periodic Adverse Drug Experience Report (PADER), as the name depicts, is an aggregate safety report that summarizes the adverse events and reactions for the approved medicinal product within a definite period (reporting interval). It is required to be submitted by a sponsor or MAH to the USFDA once authorization of the medicinal product is approved in the US. It summarizes changing post-approval adverse event profiles, safety information of an approved drug, and the benefit-risk profile evaluation.
For the initial three years, the company must submit the report quarterly within 30 days of the quarter’s close and annually within 60 days of the US approval date.
This safety report is intended to update and evaluate the global safety experience and risk-benefit profile of the medicine after approval. These evaluations help to ascertain information about changes required in the product labelling (if any) or any additional investigation to be carried out further. In addition, it acts as an interface to report new relevant safety information and create opportunities for periodic re-evaluation of safety.
ProductLife Group is one stop solution which assists organizations with successful PADER preparation and submission. PLG provides an electronic compilation of PADER and converts existing PADER to eCTD format, followed by its proposal to USFDA via Web trader/ESG gateway.
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