Following approval of a drug or biologic product, the U.S. Food and Drug Administration (FDA) may require or a sponsor may agree to conduct further studies and testing on the product. These additional studies are known as Postmarketing Requirements (PMRs) or Postmarketing Commitments (PMCs). PMRs are clinical trials or studies that sponsors are required to conduct under one or more laws or regulations and PMCs are clinical trials or studies that a sponsor agrees to conduct, but are not required by law or regulation. PMR and PMC studies are used to gather additional information about a product's safety, effectiveness, or optimal use.
To download a list of Shire’s U.S. PMRs and PMCs, click here.
The PMRs and PMCs listed include nonclinical (nonhuman), clinical (medical), and epidemiological studies that Shire has agreed to conduct to gather additional information about the safe and effective use of our approved products. This website does not contain technical chemistry, manufacturing and controls PMCs, or PMCs for products which Shire does not hold the U.S. regulatory approval.
The PMR/PMC list includes our active PMRs and PMCs and provides the following information, organized alphabetically by product name:
- Name of Product
- Application Number (FDA assigned NDA or BLA Number)
- Description of Commitment
- Date Commitment Given
- Projected Completion Date
- Commitment Status
Please note that the status of Shire’s PMRs and PMCs as well as Industry PMC’s are shown on the FDA website and may differ from the information displayed on our list because of the timing of content review and website updates. The status categories listed are consistent with categories used by the FDA and are defined below:
Pending: The study/clinical trial has not been initiated (i.e., no subjects have been enrolled or animals dosed), but does not meet the criterion for delayed (i.e., the original projected date for initiation of patient accrual or initiation of animal dosing has not passed).
Ongoing: The study/clinical trial is proceeding according to, or is ahead of, the original schedule. The FDA considers a study/clinical trial to be ongoing until a final report is submitted to the FDA, as long as the activities are proceeding according to the original schedule. If patient accrual or animal dosing has started but is not complete, and the projected date for completion of that milestone has passed, the study/clinical trial is categorized as delayed.
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 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 the sponsor has one delayed phase, but gets back on schedule during the next phase, the delayed status will no longer apply.
Terminated: The sponsor ended the study/clinical trial before completion and has not yet submitted a final report to the FDA.
Submitted: The sponsor has concluded or terminated the study/clinical trial and has submitted a final report to the FDA, but FDA has not yet notified the sponsor in writing that the PMR/PMC has been fulfilled or that the PMR/PMC has been released.
Fulfilled: The sponsor has submitted the final report for the PMR/PMC, and, upon review of the final report, FDA is satisfied that the sponsor has met the terms of the PMR/PMC.
Released: FDA has informed the sponsor that it has been released from its PMR/PMC to conduct the postmarketing study/clinical trial because it is either no longer feasible or would no longer provide useful information.
Information about Shire’s PMRs and PMCs will be updated quarterly to reflect the progress we have made in fulfilling our existing PMRs and PMCs and new commitments will be added within 30 days of the date of the commitment. Once the FDA determines a PMR or PMC is fulfilled or should not be completed, or if Shire terminates a study before the completion date, those PMRs/PMCs will be removed from our published list in cooperation with FDA.