30. Periodic Adverse Drug Experience Report (PADER/PAER)

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. 

PADERs are largely superceded by the new PBRER for hormonised use across all ICH regions. 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).

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. 

This evaluation provides insights, whether further changes are required for a medicine’s labeling or if additional investigations are required. 

Submission of a PADER starts following completion of Phase 3 trials and with approval of a new drug application ([NDA] for innovator products), abbreviated NDA ([ANDA] for generic products), and biologic license application ([BLA] for biological products) by the US FDA.

Table of Contents for a PADER:

• A narrative summary and analysis of the information in the report and an analysis of the 15-day alert reports submitted during the reporting interval (all 15-day alert reports must appropriately reference the applicant’s patient identification number, adverse reaction term(s), and date of submission to the FDA).
• A MedWatch form (3500A) for each adverse drug experience not reported as a 15-day expedited report (with an index consisting of a line listing of the applicant’s patient identification number and adverse reaction term(s)).
• A history of actions taken since the last report because of adverse drug experiences (e.g., labeling changes or studies initiated).
• Periodic reporting, except for information regarding 15-day alert reports, does not apply to adverse drug experience information obtained from postmarketing studies (whether or not they were conducted under an investigational New Drug Application), from reports in the scientific literature, or from foreign marketing experience.
• Follow-up information to adverse drug experiences submitted in a periodic report may be submitted in the next periodic report.

As regulated by the FDA, organizations need to submit these reports once in a quarter for three years within 30 days of close of quarter and later should submit these reports annually within 60 days of US approval date. The PADER / PAER submissions are solely to be made in completely electronic format, i.e. in electronic Common Technical Document (eCTD).