Blank), PMRs have a code/flag to indicate which statutory authority they are required under.
the far right column (Subpart Flag) of the download file. PMCs have no flag (field will be either Y or
You can differentiate postmarketing requirements (PMR) from postmarketing commitments (PMC) in
Web site for not more than one year from the date the commitments are fulfilled or released.
Note: The "fulfilled" and "released" commitments will be displayed on the
obligation to conduct the postmarketing study because the study is either no longer feasible or would no longer provide useful information.
Released: FDA has informed the applicant that it has been released from its
and upon review of the final study report, FDA is satisfied that the applicant has met the terms of the commitment.
Fulfilled: The applicant has submitted the final study report for the commitment,
in writing that the study commitment has been fulfilled or that the commitment has been released.
a final study report to the FDA, but FDA has not yet notified the applicant
Submitted: The applicant has concluded or terminated the study and has submitted
Terminated: The applicant ended the study before completion, and has not yet submitted a final study report to the FDA.
If the applicant has one delayed phase, but gets back on schedule during the next phase, the delayed status will no longer apply.
each phase of the study will be considered in its own right.
- not a revised schedule - serves as the basis for defining a study as delayed,
or submission of the final study report to the FDA.  While the original study schedule
Delays can occur in any phase of the study, including patient enrollment, analysis of study results,
Delayed: The progression of the study is behind the original study schedule.
date for completion of that milestone has passed, the study should be categorized as delayed.
If patient accrual or animal dosing has started but is not complete, and the projected
as long as the activities are proceeding according to the original study schedule.
The FDA considers a study to be ongoing until a final study report is submitted to the FDA,
Ongoing: The study is proceeding according to, or is ahead of, the original schedule.
projected date for initiation of patient accrual or initiation of animal dosing has not passed).
or animals dosed), but does not meet the criterion for delayed (i.e., the original
Pending: The study has not been initiated (i.e., no subjects have been enrolled
Regulation a PMR is required under.
Not applicable for PMCs
Application type
FDA Center  CB = CBER or CD = CDER
CDER is Center for Drug Evaluation and Research
CBER is Center for Biologics Evaluation & Research
Is the PMR/PMC publicly reportable Y = Yes
Product Name
Applicant Name
New Drug Application (NDA) or Biologic License Application (BLA)number
Original Final Report Due Date"
Application Approval Date
Date last PMR/PMC annual report received
Date PMR/PMC annual report due
Explanation of Status
PMR/PMC Description
Set number (NDAs) or Supplement number for BLAs (0= original BLA)
Postmarketing Commitments (PMC)
Postmarketing Requirements (PMR)
PMR/PMC Number
Internal identifier
Source File: pmc_commitments.xlsx
Source File URL: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/UCM070783.zip
Source Page: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm070777.htm
by Jean Roth , jroth@nber.org ,  3 Feb 2017