Periodic Adverse Drug experience report (PADER)

Periodic Adverse Drug experience report is a post-marketing safety report submitted to the United States Food and Drug Administration (USFDA).

The main objective is to provide summary data with an assessment of an approved drug product’s benefit risk profile from the post marketing exposure. The scope of PADER is limited to serious and unlisted cases which include concise narratives and summary analysis of 15‑day ICSR reports. It also includes the periodic cases which are submitted in the United States Region and the regulatory actions taken for safety reasons during the reporting interval since last submitted PADER.

PADER for each NDA and ANDA:

Multiple PADERs are required for each New Drug Application (NDA), Abbreviated New Drug Application (ANDA) of a product-In contrast to PBRER/PSUR (where a single report is required for active pharmaceutical ingredient irrespective of formulation)

For example, a generic medicine is having multiple ANDA numbers for different formulations (ANDA# XXXXX for Tablet formulation and ANDA# XXXXX for Capsule formulation). So here two separate PADERs need to be prepared by the respective manufacturer for submission to USFDA within the stipulated (regulatory) timeline.

Regulatory Timeline:

Two different timelines exist for PADER submissions to US-FDA.

  1. Within 30-Days: This timeline is applicable for PADER with a Quarterly reporting interval. i.e., The review period covers for the duration of 3 months.
  2. Within 60-Days: This timeline is applicable for PADER with an Annual reporting interval. i.e., The review period covers for the duration of 12 months.

PADER STRUCTURE

[As per Guideline for Post-marketing Reporting of Adverse Drug Experiences]

As per US-FDA requirements with respect to 314.80 guideline, below elements are required to present in the PADER document.

  1. Domestic ICSRs: The Individual Case Safety Reports (ICSRs) (both Initial and Follow Up cases) which are entered in the manufacturer’s drug safety database with the country of incidence-United States within the reporting interval period.
  2. SUSAR cases (15-Day Reports): The Serious Unexpected Suspected (Related) cases which are submitted to FDA during the reporting interval.
  3. Analysis: Evaluation of change in the frequency of serious listed (expected) events in comparison with the previous reporting interval and cumulatively.
  4. Regulatory actions/changes to the RSI: The significant actions taken by manufacturer as per request from regulatory body and significant changes to reference safety information (RSI) and other important safety communications related to the product for which PADER is being written.
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