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Post-Marketing Requirements

Post-Marketing Requirements & Commitments

For more than 75 years, Janssen has been helping improve health around the world. From early discovery to distribution, patient access and education, we continuously search for ways to deliver quality and value.

Continuing research on our medicines after approval by health authorities is an important part of our commitment to improving health around the world. By continuing research on our products even after market approval, we can discover important new information about safety and how our products work to help patients achieve the best possible outcome. This information influences product labeling and helps us educate and inform patients and healthcare professionals about our products.

In February 2014, Janssen began posting information on this website concerning the status of development activities agreed to with the United States Food and Drug Administration (FDA). This includes post-marketing requirements (PMRs) and post-marketing commitments (PMCs) for United States marketed products intended for human use. We will continue to include the nature and status of post-marketing development activities, including clinical, non-clinical, and pharmacovigilance studies/trials that have been identified as PMRs or PMCs.

Beginning in July 2014, we began updating the posting on a quarterly basis. Once the FDA has confirmed that a PMR or PMC has been fulfilled or released, we will continue to include information about that development activity for approximately another six months.

Additional background on PMRs is available on the FDA website. In alignment with the FDA site, Janssen will not include technical chemistry or manufacturing and control (CMC) commitments. Below is a link to a searchable PDF file of Janssen’s PMRs and PMCs. Here are the explanations of terms found in that PDF.

COLUMN HEADINGEXPLANATION
Product Name [TRADE NAME (generic name)]Trade name used in the United States market (active ingredient[s] in the drug)
Due DateThe date by when Janssen has agreed to a final submission to FDA relating to the post-marketing development activity
Activity Status (Delayed, Fulfilled, Ongoing, Pending, Released, Submitted, Terminated)The status of the requirement at the last quarterly update (see definitions below)
Description of the CommitmentA description of the development activity identified as a PMC or PMR

Janssen Pharmaceutical Companies United States Post-Marketing Commitments - April 2017

The following are the status definitions for each requirement. These definitions are consistent with those of the FDA.

  • Delayed: The progression of the study/clinical trial is behind the original schedule. Delays can occur in any phase of the study/clinical trial, including development of the final protocol, patient enrollment, analysis of results or submission of the final report to the FDA. While the original schedule—not a revised schedule—serves as the basis for defining a study/clinical trial as delayed, each phase of the study/clinical trial will be considered in its own right. If a study or clinical trial is delayed in one phase and gets back on schedule during the next phase, the delayed status will no longer apply
  • Fulfilled: A final study report for the commitment has been submitted to the FDA, and upon review of the final study report, the FDA has confirmed it is satisfied that the terms of the commitment have been met
  • Ongoing: The study is proceeding according to, or is ahead of, the original schedule. A study is ongoing until a final study report is submitted to the FDA, as long as the activities are proceeding according to the original study schedule
  • Pending: The study has not been initiated (i.e., no patients have been enrolled or animals dosed), but the original projected date for initiation of patient accrual or initiation of animal dosing has not passed
  • Released: We have been informed by the FDA that we have been released from our obligation to conduct the postmarketing study because the study is either no longer feasible or would no longer provide useful information
  • Submitted: A final study report has been submitted to the FDA, but the FDA has not yet confirmed in writing that the study commitment has been fulfilled or that the commitment has been released
  • Terminated: The study/clinical trial was ended before completion and a final report has not yet been submitted to the FDA Please note that the status and/or number of our PMRs and PMCs shown on the FDA website may differ from the information displayed on our PMC Summary Table because of the timing of content review and website updates. The status categories used in the PMC Summary Table are generally consistent with categories used by the FDA.

By providing insight into our PMRs and PMCs, we will continue to collaborate with the world for the health of everyone in it.