Prepare annual PMR, PMC and other postmarketing-study status reports

How do you assign annual PMR or PMC study status?

Retrieve the actual obligation, original schedule, prior revisions and study evidence at the reporting cutoff. Apply the relevant regulatory status definitions and explain progress or delay. Preserve enrollment, completion and final-report submission records, and continue the applicable annual reporting until FDA provides the specified written closure. Submitted and fulfilled are different dispositions.

Before you begin

Applicable NDA/ANDA reports under 314.81(b)(2)(vii–viii) and BLA reports under 601.70, with other studies assessed under the relevant framework.

What you will prepare: A reconciled obligation register and study-specific annual status narratives.

Start from the exact commitment or requirement

Collect approval and postapproval letters, commitment identifiers, exact wording, original milestone dates and all later FDA correspondence. Distinguish a legally required study from a study the applicant committed to conduct; do not decide the category from a project's internal label.

Build a register with application/product, obligation identifier, legal or commitment basis, objective/population, protocol identifier, original schedule, previously submitted revisions, current proposed schedule, status at the reporting cutoff, evidence reference and owner. Retain original milestones even when the internal project plan has moved.

1.13.12: make the regulated study status reproducible

For the applicable clinical safety, efficacy, clinical pharmacology and nonclinical toxicology studies, provide the required application identity, commitment date, study description, schedule, current status and explanation. Use the regulatory status terms, pending, ongoing, delayed, terminated or submitted, with their actual definitions.

A study behind the original schedule cannot be relabeled ongoing merely because it follows a recently revised internal schedule. Explain enrollment to date and planned enrollment where relevant, the milestone change, reason and corrective plan. Reconcile completion and report-submission dates with the actual records.

Continue reporting the applicable status until FDA's written notification establishes the recognized fulfilled or other closure disposition. A final report receipt or internal “done” flag is not the same as FDA concurrence. For pediatric requirements, coordinate current due-diligence and any deferral-extension issues with the responsible owner; annual reporting does not itself extend a deadline.

1.13.13: keep other studies and CMC work visible

314.81(b)(2)(viii) separately addresses other postmarketing studies, including agreed CMC studies and product stability studies. Identify what was promised, the batches/process/products involved, work completed during the interval, findings and the next milestone. Do not remove this work from the report because it is absent from a public clinical PMR list.

A practical stability-status entry identifies the commitment, batches/presentations, available time points, significant findings, expected remaining work and where the underlying data reside. For a BLA, establish the relevant reporting basis rather than automatically importing the NDA/ANDA other-study provision. A safety or quality finding may also trigger a separate action outside the annual cycle.

Worked review: submitted is not fulfilled

Fictional editorial exercise: a final study report was submitted, but FDA has not issued a fulfillment letter. The annual report removes the study from the register. Restore the applicable status and preserve the submission reference until the proper closure is documented.

Change the scenario to an ongoing stability commitment that is not a clinical PMR. It still needs the appropriate other-study assessment. If the original letter or schedule is missing, recover it before assigning a status; a project team's current target cannot reconstruct the agency baseline.

Assign the status from milestones and submission evidence

Use these definitions for studies within §314.81(b)(2)(vii) or §601.70. Assess other CMC and stability work under its own applicable reporting basis instead of assuming every study uses the same public status framework.

Preserve both the original schedule and the most recent previously submitted revision when the schedule has changed. An internal project plan is useful management information, but it must not replace the regulatory baseline. Include the reason for a new revision and the applicable enrollment information so the status is understandable rather than a color in a tracker.

Schedule exercise: the original final-report milestone has passed. An internal steering group approves a later target and the study now meets that target. The later plan does not make the study on time against the original schedule. Report the actual status, explain the cause and provide the revised schedule. If there is FDA correspondence affecting the obligation, preserve and assess that exact record instead of inferring its meaning from the team’s new date.

Termination exercise: a study ended early and its final report was subsequently submitted. The applicable definition of submitted includes terminated studies with a submitted final report. Preserve the reason for termination and actual submission date; do not infer successful completion or FDA fulfillment from that status.

For a BLA report under §601.70, the regulation also specifies a completed Form FDA 2252 with the annual progress report. The fact that BLA content differs from an NDA annual report does not remove that shared transmittal requirement. Use the current form and submission instructions when preparing the actual package.

For closure, retrieve the FDA notification that addresses the study commitment. A transmission receipt confirms delivery, and a final study report documents the study; neither alone establishes FDA concurrence with fulfillment or the other recognized closure grounds. Continue the applicable reporting while that disposition remains pending.

Keep the NDA/ANDA annual report synchronized with the obligation register. Other-study reporting under §314.81(b)(2)(viii) includes agreed CMC studies and all product stability studies; absence from a public clinical-study list does not establish that no reporting is needed.

Frequently asked questions

Sources and revisions

Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.

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