How to Fill Out FDA Form 3989 (w/Examples) + FAQs

FDA Form 3989 is a standardized form pharmaceutical and biologics companies use to report on the progress of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for approved drugs and biologics. Under 21 CFR 314.81(b)(2)(vii) and 21 CFR 601.70, applicants must submit annual status reports (ASRs) on all open PMRs and PMCs until FDA notifies them in writing that each requirement has been fulfilled or released. Failure to comply with PMR obligations can result in products being declared misbranded under Section 502(z) of the FD&C Act, triggering warning letters, civil monetary penalties up to $10 million per proceeding, and potential product seizure.

According to FDA data, approximately 14-15% of open PMRs have a “delayed” status at any given time, and the agency has issued warning letters to companies like Merck for failing to meet agreed-upon milestone dates.

📋 What You’ll Learn:

• ✅ How to complete every field on Form FDA 3989 with real-world examples
• 📅 When and how to submit your annual status report to avoid penalties
• ⚠️ Critical mistakes that cause form rejection or compliance violations
• 🔢 Understanding the five PMR/PMC status categories and what they mean
• 💼 Step-by-step guidance for domestic and foreign applicants

What Is FDA Form 3989 and Why Does It Matter?

FDA Form 3989, officially titled “PMR/PMC Annual Status Report for Drugs and Biologics,” serves a specific purpose within FDA’s postmarketing surveillance system. The form allows pharmaceutical companies to report annually on studies or clinical trials they are required (PMRs) or have agreed in writing (PMCs) to conduct after FDA approves their drug or biologic product.

The form exists because Congress mandated better tracking of postmarketing studies. The FDA Food Safety Modernization Act (FDAMA) of 1997, the FDA Amendments Act (FDAAA) of 2007, and subsequent legislation gave FDA authority to require certain postmarketing studies and clinical trials. Section 506B of the FD&C Act requires annual reporting on these studies.

Who Must File Form 3989?

Form 3989 applies to holders of these application types:

The form is optional but strongly encouraged by FDA because it enables automated processing and improves data accuracy in FDA’s internal databases. However, when an applicant chooses to use Forms 3988 or 3989, they must submit them electronically.

Types of Postmarketing Requirements vs. Commitments

Understanding the difference between PMRs and PMCs proves essential before completing Form 3989.

Postmarketing Requirements (PMRs)

PMRs are studies or clinical trials that FDA requires applicants to conduct by statute or regulation. FDA can require PMRs under these authorities:

Postmarketing Commitments (PMCs)

PMCs are studies or clinical trials that applicants agree in writing to conduct after approval but are not required by statute or regulation. Unlike PMRs, failure to conduct a PMC does not constitute a violation of the FD&C Act. However, applicants must still report annually on PMC status under Section 506B.

Step-by-Step Guide: Every Field on Form FDA 3989

The following breakdown covers each field on Form 3989 based on the official FDA instructions.

Fields 1-10: Application Information

Field 1: Center
Select the FDA center that approved or licensed your application. Choose only one option:

• CDER – Center for Drug Evaluation and Research (for most drugs)
• CBER – Center for Biologics Evaluation and Research (for biologics)

Field 2: Date of Submission
Enter the date you are submitting the form using the mm/dd/yyyy format. This date should match the cover letter date accompanying your submission.

Example: If submitting on March 15, 2026, enter “03/15/2026”

Field 3: Applicant Name
Enter the legal name of the applicant. For NDAs and ANDAs, this is the person who submitted the application or owns the approved application under 21 CFR 314.3. For BLAs, enter the name of the person or legal entity holding the license.

Example: “Acme Pharmaceuticals, Inc.”

Field 4: Application Type
Select only one checkbox:

• NDA (New Drug Application)
• ANDA (Abbreviated New Drug Application)
• BLA (Biologics License Application)

Field 5: Application Number
Provide the six-digit application number. For numbers with fewer than six digits, add leading zeros.

Field 6: Established Name
Enter the drug’s established name—typically the United States Pharmacopeia (USP) or United States Adopted Name (USAN).

Example: “metformin hydrochloride” (not “Glucophage”)

Field 7: Proprietary Name(s)
Enter the trade name, if any.

Example: “Glucophage XR”

Field 8: Date of U.S. Approval
Enter the date FDA approved or licensed the application using mm/dd/yyyy format. This is the date on your FDA approval letter.

Field 9: Alternate Annual Status Report Due Date
Complete this field only if FDA formally granted you an alternate reporting date through a waiver request under 21 CFR 314.90. Companies sometimes request alternate dates to harmonize reporting across international regulatory agencies or multiple applications.

Field 10: Period Covered by Report
Enter the year and month reflecting the current reporting period (yyyy/mm format). This field is optional but helpful.

Section 11: PMR/PMC Update (Repeat for Each PMR/PMC)

Section 11 is the core of Form 3989. You must complete this section separately for each open PMR or PMC. Use the “Add Item 11” button to add additional PMRs/PMCs.

Field 11.a.: PMR/PMC Number
Enter the PMR or PMC number using the center-specific format:

Field 11.b.: PMR/PMC Establishment Date
Enter the date of the letter in which FDA first communicated the final PMR or PMC. This is usually the approval letter or a post-approval “Acknowledge New PMR/PMC” letter.

Example: “06/15/2024”

Field 11.c.: Supplement Number
If the PMR/PMC was established in a supplement (rather than the original application), enter the four-digit supplement number preceded by the original application number.

Example: For supplement 003 to NDA 012345, enter “012345-0003”

Field 11.d.: Study/Trial Title
Enter the name of the study or clinical trial. You may also include:

• Purpose of the study/trial
• Type of study/trial
• Patient population
• Indication(s) and dosage(s) being studied

Critical: For clinical trials required under Section 505(o)(3), you must include the NCT number (ClinicalTrials.gov identifier) if available, or submit Form FDA 3674 (Certification of Compliance with ClinicalTrials.gov).

Example: “A Phase 4, Randomized, Double-Blind Study to Evaluate Cardiovascular Outcomes in Patients with Type 2 Diabetes (NCT04123456)”

Field 11.e.: PMR/PMC Description
Enter the PMR or PMC description exactly as communicated in the establishment letter (usually the approval letter).

Example: “Conduct a prospective, observational cohort study to evaluate the incidence of hepatotoxicity in patients treated with [Drug X] for at least 12 months.”

Field 11.f.: Current Enrollment
For clinical studies, enter the number of subjects enrolled to date as a fraction of total expected enrollment.

Field 11.g.: Study/Trial Status

Select the current open status from the dropdown list. You only report on open PMRs/PMCs—do not include those with “fulfilled” or “released” status.

Important: The status is based on the original timetable, not revised schedules—unless FDA granted a PREA deferral extension for the final report submission date.

Field 11.h.: Explanation of Status
Provide a concise explanation of how the study is progressing relative to the original projected schedule. This explanation appears on FDA’s public PMR/PMC database for delayed or terminated studies and all PREA PMRs.

Do not include confidential commercial or trade secret information in this field.

Example for Ongoing: “Enrollment proceeding as planned. Currently at 75% of target enrollment with expected completion date of Q3 2026.”

Example for Delayed: “Enrollment slower than projected due to limited patient population meeting inclusion criteria. Working with additional study sites to accelerate recruitment.”

Field 11.i.: Milestone Information
Enter dates for each milestone type using mm/dd/yyyy format:

For each milestone:

• Original Date (X.b.): Enter the date from the PMR/PMC establishment letter
• Revised Date (X.c.): Enter only if dates have changed; check “Check if New” for newly proposed revisions not yet acknowledged by FDA
• Check if not applicable: Use this checkbox if a milestone type does not apply to your PMR/PMC

Field 11.j.: Revised Reason
If you entered revised dates, explain the reason for the revision (e.g., slow patient accrual, manufacturing delays). If proceeding on schedule with no revised dates, enter “N/A” or “not applicable.”

Fields 12-19: Certification and Signature

Field 12.a.: Name and Title of Applicant’s Responsible Official
Enter the name and title of the person responsible for certifying compliance with applicable laws. This person signs Field 18.

An authorized U.S. Agent may act as the Responsible Official.

Field 12.b.: Date
Enter the date the form is signed (mm/dd/yyyy).

Fields 13-15: Contact Information
Provide telephone number, fax number (if applicable), and email address for the Responsible Official.

Field 16: Address of Applicant’s Responsible Official
Provide the full address of the Responsible Official.

Field 17: Address of Authorized U.S. Agent
Required for non-U.S. applicants. If the applicant is located outside the United States, provide the U.S. Agent’s address.

Field 18: Signature
The form must be signed by the applicant, or the applicant’s attorney, agent, or other authorized official under 21 CFR 314.50(a)(5) and 21 CFR 601.2(a).

Field 19: Countersignature of Authorized U.S. Agent
If the person signing Field 18 does not reside or have a place of business in the United States, an attorney, agent, or authorized official within the U.S. must countersign in this field.

Three Common Scenarios: Action and Consequence Tables

Scenario 1: On-Track Cardiovascular Outcomes Trial

Situation: A pharmaceutical company received NDA approval in 2024 with a PMR to conduct a 5-year cardiovascular outcomes trial (CVOT). The company is now submitting its first annual status report in 2025.

Scenario 2: Delayed Pediatric Study (PREA PMR)

Situation: A company’s PREA-required pediatric study has fallen behind the original schedule due to challenges recruiting pediatric patients.

Scenario 3: Foreign Applicant Submitting Annual Status Report

Situation: A European pharmaceutical company holds an NDA for a drug marketed in the United States and must submit its PMR/PMC annual status report.

Submission Requirements: When and How to File

Timing Requirements

Electronic Submission Process

Form 3989 must be submitted electronically through the electronic Common Technical Document (eCTD) format.

Submission location: Include Form 3989 in eCTD Section 1.13.12 (Status of Postmarketing Commitments and Requirements).

Do not submit both a company-derived ASR and Form 3989 in Section 1.13.12—choose one or the other.

Form FDA 2252 Requirement: You must also submit Form FDA 2252 (Transmittal of Annual Reports for Drugs and Biological Products for Human Use) with your Form 3989.

Mistakes to Avoid

The following errors cause compliance issues, form rejection, or enforcement action:

Enforcement Actions and Penalties

FDA has several enforcement tools for PMR noncompliance, particularly for PMRs established under Section 505(o)(3) of the FD&C Act:

Warning Letters

FDA typically issues a Warning Letter before pursuing formal enforcement actions, giving companies an opportunity to voluntarily come into compliance. However, FDA is not obligated to provide prior notice through a Warning Letter before taking enforcement action.

Real-World Example: In February 2012, FDA issued a Warning Letter to Merck for failing to meet PMR milestones for Januvia® and Janumet®. Merck had agreed to conduct a 3-month pancreatic safety study in a diabetic rodent model. When Merck failed to submit a draft protocol and was “more than 20 months late” in achieving milestones, FDA declared the products misbranded under Section 502(z).

Misbranding Under Section 502(z)

Under Section 502(z) of the FD&C Act, a drug is considered misbranded if the applicant violates a PMR established under Section 505(o)(3). Misbranding can trigger:

• Product seizure
• Injunctions
• Criminal prosecution

Civil Monetary Penalties

Note: As of late 2024, FDA had never imposed civil monetary penalties specifically for delayed confirmatory trials after accelerated approval, despite having this authority since 2007.

Accelerated Approval Consequences

For drugs approved under accelerated approval, failure to complete confirmatory PMRs can result in FDA initiating proceedings to withdraw the approval.

Do’s and Don’ts

Do’s

Don’ts

Key Entities and Their Roles

Understanding the relationships between entities helps navigate the PMR/PMC reporting system:

Pros and Cons of Using Form FDA 3989

Pros

Cons

State-Level Considerations

FDA Form 3989 is a federal requirement governed by the FD&C Act and implementing regulations. State-level pharmacy boards and health departments generally do not have separate PMR/PMC reporting requirements for drug manufacturers. States rely on FDA’s national oversight of postmarketing study obligations.

However, state attorneys general may pursue enforcement actions under state consumer protection laws if a company’s failure to complete PMRs results in patient harm or constitutes unfair/deceptive practices. State Medicaid programs may also factor FDA compliance status into formulary decisions.

FAQs

Is Form 3989 mandatory for all PMR/PMC annual status reports?
No, Form 3989 is optional. FDA encourages its use for standardization, but applicants may still submit company-derived ASRs in eCTD Section 1.13.12.

Can I report PMRs/PMCs from multiple applications on one Form 3989?
No, each Form 3989 covers only one application number. Submit separate forms for each NDA, ANDA, or BLA with open PMRs/PMCs.

What happens if my study status changes from “Ongoing” to “Delayed” mid-year?
Yes, report the current status at the time of your ASR submission. If delayed, explain the circumstances in Field 11.h. and consider proposing revised milestones in Field 11.i.

Do I need to report on PMRs/PMCs that FDA has “fulfilled”?
No, you only report on open PMRs/PMCs. Those with fulfilled or released status do not require updates.

What is the penalty for submitting my ASR late?
Yes, late submissions violate reporting requirements under 21 CFR 314.81 and 601.70. Repeated late filings may trigger Warning Letters and, for Section 505(o)(3) PMRs, civil monetary penalties up to $10 million.

Can a non-U.S. company submit Form 3989 without a U.S. Agent?
No, non-U.S. applicants must provide U.S. Agent information in Field 17, and the U.S. Agent must countersign Field 19 if the Responsible Official is located outside the United States.

Does Form 3989 replace the need for Form FDA 2252?
No, you must still submit Form FDA 2252 as a transmittal document alongside Form 3989 for NDA and BLA annual reports.

How do I determine if my clinical trial needs an NCT number?
Yes, if your PMR is a clinical trial required under Section 505(o)(3) of the FD&C Act, it must be registered on ClinicalTrials.gov, and you should include the NCT number in Field 11.d.

What “good cause” can justify a delayed PMR?
Yes, good cause may include scientific or logistical reasons outside the applicant’s control. FDA’s guidance on “good cause” specifies acceptable justifications, such as patient recruitment challenges or manufacturing difficulties that could not have been reasonably anticipated.

Does using Form 3989 provide any regulatory advantage?
Yes, FDA encourages use of the standardized form because it improves data accuracy in FDA’s internal databases and enables automated processing, which may expedite FDA’s review of your ASR.