Submission of a PADER starts following completion of Phase 3 trials and with approval of a new drug application ( for innovator products), abbreviated NDA ( for generic products), and biologic license application ( for biological products) by the US FDA. This evaluation provides insights, whether further changes are required for a medicine’s labeling or if additional investigations are required.
The main purpose of a PADER is to update and evaluate a medicine’s global data and provide information about drug safety. It provides a brief summary of changing post-approval information of a drug along with the benefit-risk profile evaluation.
As per 21 Code of Federal Regulations (CFR) 314.80 US FDA recommends periodic submission of a PADER, MAH can submit PSUR/PBRER along with NDA listings (also called US Supplement/FDA PSUR) in place of PADER after obtaining a waiver per 314.90 (b) and 600.90 (b). PADERs are largely superceded by the new PBRER for hormonised use across all ICH regions. A PADER is a type of aggregate safety report required to be submitted by a sponsor or marketing authorization holder (MAH) to the US Food and Drug Administration (FDA) after obtaining marketing authorization approval as per 314.80 (C) (2) and 600.80 (C)(2) guidelines.
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