PADER Structure in detail you need to know

All about Pharmacovigilance, Pharmacovigilance in USA -FDA / By

GlobalVigiPub provides you the free online pharmacovigilance training via the posts page on our website. This Guidance on drug safety is good enough to understand the Pharmacovigilance basics and get the roots of pharmacovigilance in detailed too. Just browse the posts and read to get the knowledge on Pharmacovigilance course.

PADER Structure in detail

Ques: What must be included in PADERs and what Format must be followed by MAH.

Ans: As per Guideline from FDA 314.80, the below is the details and format of PADER.

  1. Narrative summary: A narrative summary and analysis of the information submitted during the reporting period must  include
    • The number of non-15-day initial adverse experience reports and the number of non-15-day follow-up reports contained in this periodic report and the time period covered by the periodic report.
    • A line listing of the 15-day reports submitted during the reporting period. This line listing should include the manufacturer report number, adverse experience term(s), and the date the 15-day report was sent to the FDA.
    • A summary tabulation by body system (e.g., cardiovascular, central nervous system, endocrine, renal) of all adverse experience terms and counts of occurrences submitted during the reporting period. The information should be taken from
      • 15-day reports submitted to the FDA;
      • non-15-day reports submitted in the periodic report;
      • reports forwarded to the applicant by the FDA; and
      • any non-serious, expected adverse experiences not submitted to the FDA but maintained on file by the applicant.
    • For the adverse experience term product interaction, the interacting products should be identified in the tabulation
    • A summary listing of the adverse experience reports in which the drug or biological product was listed as one of the suspect products, but the report was filed to another NDA, ANDA, or BLA held by the applicant.
    • A narrative discussion of the clinical significance of the
      • 15-day reports submitted during the reporting period,
      • Any increased reporting frequency of serious, expected adverse experiences when, in the judgment of the applicant, it is believed the data reflect a clinically meaningful change in adverse experience occurrence.
      • Assessment of clinical significance by type of adverse experience, body system, and overall product safety relating the new information received during this reporting period to what was already known about the product.
      • should also state what further actions, if any, the applicant plans to undertake based on the information gained during the reporting period and include the time period for completing the actions (i.e., when the applicant plans to start and finish the action and submit the information to the Agency).
    • The narrative discussion should indicate, based on the information gained during the reporting period, whether the applicant believes either that
      • No change in the product’s current approved labelling is warranted or
      • There are safety-related issues that need to be addressed in the approved product labelling. If changes in the approved product labelling are under consideration by the FDA, the applicant should state in the narrative the date and number of the supplemental application submitted to address the labelling changes.
  2. Narrative discussion of actions taken: A narrative discussion of actions taken must be provided, including any labeling changes and studies initiated since the last periodic report. This section should include
    • A copy of current U.S. product labeling.
    • A list of any labeling changes made during the reporting period.
    • A list of studies initiated.
    • A summary of important foreign regulatory actions (e.g., new warnings, limitations in the indications and use of the product).
    • Any communication of new safety information (e.g., a Dear Doctor letter)
  3. An index line listing of FDA Form 3500As or VAERS forms report must be provided. The line listing for each FDA Form 3500A or VAERS form submitted should include:
    • Manufacturer report number
    • Adverse experience term(s)
    • Page number of FDA Form 3500A or VAERS form as located in the periodic report.  Identification of interacting products for any product interaction listed as an adverse experience.
      • FDA Form 3500As or VAERS forms must be provided for Spontaneous, Domestic
        • Serious and expected
        • Non serious and unexpected
        • Non serious and expected
      • Adverse experiences due to a failure to produce the expected pharmacologic action (i.e., lack of effect) should be included in this section.
  4. Waivers taken if any
    • Note: An FDA Form 3500A or VAERS form for a serious, unexpected adverse experience should not be included in a periodic report because this adverse experience should have been previously submitted to the FDA as a 15-day report.
    • Note: If no adverse experiences were identified for the human drug or biological product for the time period involved and no regulatory actions concerning safety were taken anywhere in the world where the product is marketed, the periodic report should simply state this and be submitted to the FDA along with a copy of the current U.S. labelling.

Readers Note: A product is considered as standout product in the hair regrowth industry. Profollica can regenerate the follicular growth which results your hair back

Readers Note: Provillus Hair Loss Treatment. Why more people are turning to it to prevent hair loss for MEN, for WOMEN and regrow hair with the only FDA approved ingredient on the market

  • Special scenarios reports inclusion in PADER:
    • Overdose:
      • If the adverse experience is serious and expected, non serious and unexpected, or non serious and expected, a non-15 day report should be submitted in the periodic report.
    • Lack of effect:
      • All spontaneously reported cases of a lack of effect that occur in the United States should be reported on FDA Form 3500A and submitted in the periodic report with other adverse experiences. The lot number of the suspect product should be included in item C6 of FDA Form 3500A.
      • If the report of lack of effect is for an unapproved indication, the event should not be reported to the FDA as an individual case safety report. Instead, this information should be included in the narrative summary section of the periodic report.
    • Multiple suspect products:
      • If a reportable adverse experience involves two or more suspect products from the same applicant, only one FDA Form 3500A should be completed. The FDA Form 3500A should reference only one manufacturer report number. The report should be submitted to the NDA, ANDA, or BLA considered most suspect by the initial reporter.
      • If each product is equally suspect, the report should be submitted to the product first in alphabetical order. The adverse experience should also be reported in the narrative summary section of the periodic report for the other product(s).
    • Product defects:
      • 15-day report for a serious, unexpected adverse experience or periodic report for a non serious, unexpected adverse experience).

Readers Note: Fight Back against Viruses and Inflammation and Promote Proper Immune System Function with Extract of Curcumin 2000

error: Content is protected !!