RxLogix Corporation
Periodic Adverse Drug Experience Report
(PADER)
Agenda
• Objectives of PADER
• Periodicity
• PADER Sections
• Combination PADER
• Criteria for Different Section in PADER
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Objectives of PADER
• This report is specific to US FDA
• PADERs are aggregate safety reports to be submitted to the Food and
Drug Administration (FDA) for products approved for marketing in the
United States (US).
• PADER submission starts once marketing authorization approval is
received for a medicinal product.
• A separate PADER is to be submitted with each NDA approval (for
different indications and/or formulations of an investigational medicinal
product)
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Periodicity
• PADER is submitted quarterly for the first 3 years after approval in US
and annually thereafter
• PADER should be submitted within 30 calendar days if PADER Reporting
Period is 3 months
• PADER should be submitted within 60 calendar days if PADER Reporting
Period is annual
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What does PADER include
It includes –
• All the 15-day alerts (serious unlisted domestic and foreign cases) submitted during
reporting interval.
• All non-15-day alerts (serious listed, nonserious unlisted, and nonserious listed domestic
cases) reported during the reporting interval.
• Summary tabulation for all the adverse events (preferred terms as per the latest MedDRA)
by SOC for all the cases submitted to FDA for the NDA number.
• Cases where the medicinal product is reported as a co-suspect medication as well.
• Line listing of Malfunction cases
• Adverse Event by System Organ Class (Malfunction)
• Line listing of Remedial Action Cases
• Adverse Event by System Organ Class (Remedial Action)
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Sections in PADER
Common Sections
• PADER 15-day Submitted Report
• PADER Non-Expedited Cases
• Cases Submitted under Another NDA
• Number of Adverse Event Preferred Terms by Body System, Seriousness,
Listedness and Geographic
Additional Sections (Combination PADER)
• Line listing of Malfunction cases
• Adverse Event by System Organ Class(Malfunction)
• Line listing of Remedial Action Cases
• Adverse Event by System Organ Class(Remedial Action)
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What is Combination PADER
• Combination products are therapeutic and diagnostic products that
combine drugs, devices, and/or biological products.
• Combination PADER is the PADER Report which includes separate
sections for summarising device related information
• Following sections are in general utilized in additional to PADER
mandatory section to generate Combination PADER
– Line listing of Malfunction cases
– Adverse Event by System Organ Class(Malfunction)
– Line listing of Remedial Action Cases
– Adverse Event by System Organ Class(Remedial Action)
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PADER 15 day Submitted Report
• This Line Listing section displays the cases that have one or more
expedited FDA submissions to the selected license in the reporting period
• Criteria :
o Cases submitted to FDA in an expedited manner (Timeframe <= 15)
o Submission for the selected drug-license (also called as NDA license)
o Submission Date is within the reporting period
• Cases are grouped by:
o Domestic / Foreign
o Report Type
o Initial / Follow-up (Aggregate Level)
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PADER 15-day Submitted Report
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PADER Non-Expedited Cases
• This Line Listing section displays non-expedited cases that are received in the
reporting period.
• Criteria for non-expedited cases is as below:
o Spontaneous Case
o US Domestic Case (Country of Incidence: AMERICAN SAMOA, GUAM;MARSHALL ISLANDS, MICRONESIA
FEDERATED STATES OF, NORTHERN MARIANA ISLANDS, PUERTO RICO, UNITED STATES, UNITED STATES MINOR
OUTLYING ISLANDS, VIRGIN ISLANDS, U.S)
o Case is not present in the 15-Day section
o Includes Non-Serious cases and Serious Listed cases
o Initial or Significant Follow-up Receipt Date lies in the reporting period
• Cases are grouped by:
o Initial / Follow-up (Aggregate Level)
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PADER Non-Expedited Cases
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Cases Submitted under Another NDA
• Line Listing section
• Section display cases that match below all criteria:
o Case has multiple company suspect drugs
o Case does not have an expedited submission for the selected drug-
license
o Case was submitted to FDA under another US license in the reporting
period
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Cases Submitted under Another NDA
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Number of Adverse Event Preferred Terms by Body
System, Seriousness, Listedness and Geographic
• Data Tabulation
• This section includes all events from cases in below PADER line listings
o PADER 15 day Submitted Report
o PADER Non-Expedited Cases
o Cases Submitted under Another NDA
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Number of Adverse Event Preferred Terms by Body System,
Seriousness, Listedness and Geographic
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Line Listing of Malfunction Reports
Criteria: All the malfunction reports which are submitted to FDA for the Device-Combination Product
Note: In general, Report time frame for these cases is 30 day
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Summary Tabulation of Malfunction Reports
Criteria: Cases appearing in Malfunction Section
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Line Listing of Five-day Submitted Reports(Remedial
Action
Criteria: All the cases for which remedial action are taken and submitted to FDA for the Device-
Combination Product.
Note: In general, Report time frame for these cases is 5 day
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Summary Tabulation of Five-day Submitted Reports
(Remedial Action)
Criteria: Cases appearing in Remedial Action section
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