When Is FDA Form 2253 Required? (w/Examples) + FAQs

FDA Form 2253 is required every time a pharmaceutical or biologic company creates promotional materials or advertisements for approved prescription drugs and submits them to the FDA. Federal regulation 21 CFR 314.81(b)(3)(i) mandates that companies submit these materials at the exact time they first disseminate or publish promotional content. Failure to submit this form results in misbranding violations that can trigger warning letters, civil penalties up to $500,000, and even criminal prosecution.

In fiscal year 2024, the FDA received over 70,960 Form 2253 submissions containing more than 149,516 different advertisements, showing the massive scale of promotional compliance in the pharmaceutical industry.

In this article, you will learn:

📋 Exactly when FDA Form 2253 is required versus when it’s exempt from submission

💊 How to complete each section of the form correctly, including all 13 fields and 40+ material type codes

⚠️ The specific penalties and enforcement actions for failing to submit or submitting incorrectly

🔍 Real-world examples of companies that received warning letters for Form 2253 violations

✅ Step-by-step scenarios showing proper submission timing for different promotional materials

What Is FDA Form 2253?

FDA Form 2253 is the official transmittal document titled “Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use.” This form serves as the cover sheet that accompanies all promotional materials submitted to the FDA’s Office of Prescription Drug Promotion (OPDP) within the Center for Drug Evaluation and Research (CDER) or the Advertising and Promotional Labeling Branch (APLB) within the Center for Biologics Evaluation and Research (CBER).

The form creates a paper trail between drug companies and the FDA. It documents what promotional materials exist, when they were first used, and who bears responsibility for their content. The FDA uses this information to review promotional communications and ensure they meet truthfulness standards.

Form 2253 applies to both prescription drugs approved under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), as well as biological products licensed under Biologics License Applications (BLAs). Manufacturers of generic drugs have the same submission obligations as brand-name manufacturers when they create promotional materials.

The Legal Foundation: Why Form 2253 Exists

Two primary federal regulations create the Form 2253 requirement. For prescription drugs, 21 CFR 314.81(b)(3)(i) states that applicants “shall submit specimens of mailing pieces and any other labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement.”

For biological products, 21 CFR 601.12(f)(4) creates parallel requirements. Both regulations mandate that each submission include a completed Form FDA 2253 and a copy of the product’s current professional labeling (package insert).

These regulations trace back to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits drug advertising that is false or misleading. The submission requirement allows the FDA to monitor promotional activities and take enforcement action when violations occur.

When Is FDA Form 2253 Required?

Standard Postmarketing Submissions

Form 2253 is required for all promotional materials for approved prescription drugs and biologics at the time of their first use. This includes any labeling or advertising created to promote the product. The timing is critical: submission must occur at the time of initial dissemination, not before or significantly after.

“Initial dissemination” means the first moment a promotional piece reaches its intended audience. For print advertisements, this is the publication date of the magazine or journal. For direct mail, this is the mailing date. For television commercials, this is the first broadcast date.

Materials That Require Form 2253

The following promotional materials require Form 2253 submission:

Print Materials:

• Journal advertisements
• Brochures and booklets
• Detail aids for sales representatives
• Direct mail pieces
• Reprint carriers
• Sample cartons with promotional content
• Price lists
• Formulary kits

Broadcast Materials:

• Television advertisements
• Radio advertisements
• Video news releases

Digital Materials:

• Product websites
• Email campaigns
• Social media posts (Facebook, Instagram, Twitter)
• Mobile applications
• Banner advertisements
• Sponsored links
• Internet audio and video content
• QR codes with promotional content

Other Materials:

• Training materials for healthcare professionals
• Telephone scripts
• Exhibit displays
• Slide presentations
• Press releases with promotional claims

Special Requirements: Accelerated Approval Products

Drugs and biologics approved through the accelerated approval pathway face stricter promotional submission rules. These products receive approval based on surrogate endpoints before full clinical benefit is confirmed, creating heightened FDA scrutiny of promotional claims.

For accelerated approval products, two distinct submission windows apply:

This “presubmission” requirement exists because the FDA recognizes that limited clinical data may make physicians and patients especially vulnerable to misleading promotion. The agency wants to review materials before they reach the public.

Example Scenario: Accelerated Approval Drug Launch

When Form 2253 Is NOT Required

Several categories of materials and products fall outside the Form 2253 requirement:

Reminder Advertisements

Reminder ads are exempt from standard requirements if they only include:

• The drug’s proprietary (brand) name
• The drug’s established (generic) name
• Dosage form
• Quantity of package contents
• Price
• Manufacturer name and address

Reminder ads cannot mention indications, dosage recommendations, or any disease-related information. Most importantly, reminder advertising is prohibited for drugs with boxed warnings (black box warnings). A company cannot use a reminder ad for any product with serious safety concerns that warrant a boxed warning.

Help-Seeking and Disease Awareness Communications

Help-seeking advertisements describe a disease or condition but do not recommend or suggest specific drug products. These ads might say “Talk to your doctor about treatment options for allergies” without naming any particular medication.

Because these communications do not promote a specific product, they fall outside FDA jurisdiction and do not require Form 2253 submission. However, if the ad creates a connection between a disease and a specific product—even through subtle visual or audio cues—it crosses into promotional territory and requires submission.

Over-the-Counter (OTC) Drugs

The FDA does not regulate advertising for over-the-counter drug products. The Federal Trade Commission (FTC) has jurisdiction over OTC advertising. However, the FDA still regulates OTC labeling, which includes the physical packaging and any materials that accompany the product.

Pre-Approval Communications

Before a drug receives FDA approval, companies cannot promote the product for commercial purposes. 21 CFR 312.7 prohibits promoting investigational drugs as safe or effective. Therefore, Form 2253 does not apply to investigational drugs because no legitimate promotional materials should exist.

However, if a company violates this rule and promotes an unapproved drug, the FDA can take enforcement action for both the illegal promotion and the failure to submit on Form 2253.

How to Complete Form FDA 2253: Line-by-Line Instructions

The current version of Form FDA 2253 contains 13 numbered fields. The FDA provides detailed instructions for completing each section correctly.

Field 1: Date Submitted

Enter the date you send the form and materials to the FDA. Use the format MM/DD/YYYY. This date should match or be very close to the dissemination date of your promotional materials.

Field 2: Application Information

Select the application type from the dropdown menu:

• NDA – New Drug Application
• ANDA – Abbreviated New Drug Application
• BLA – Biologics License Application
• PMA – Premarket Approval Application
• CDER IND – Only for Emergency Use Authorization products

Enter the six-digit application number. Choose either “Single Product” or “Multiple Products.”

Single Product Submissions: Use when all materials relate to one drug and one application number. Each Form 2253 should cover only one product.

Multiple Product Submissions: Use for materials mentioning multiple products, such as price lists, formulary compilations, or corporate communications. List the primary application number on the form and attach a separate sheet listing all other products referenced.

Field 3: Proprietary Name

Enter the brand name of the drug exactly as it appears on FDA-approved labeling. Include the dosage form if it distinguishes your product from others with the same name (for example, “Tylenol Extended Release” versus “Tylenol Regular Strength”).

Field 4: Established Name

Enter the generic name of the drug. For biological products, include the Product Code Number if applicable.

Field 5: Package Insert Date and ID Number

Provide the date and identification number of the most current FDA-approved prescribing information. You must include a copy of this labeling with your submission. For paper submissions, include two copies.

Field 6: Manufacturer Name and License Number

Enter the manufacturer’s name. For biological products submitted to CBER, include the license number.

Field 7: Advertising/Promotional Labeling Materials

This is the core section where you list every promotional item in your submission. Each material gets its own row with six subfields:

7a. Professional or Consumer: Select only one audience type. If materials target both audiences, select the primary audience and note the mixed audience in the Comments section.

7b. Material Type: Use one of the 40+ FDA material type codes. Common codes include:

7c. Dissemination/Publication Date: Enter the date of first use. Format: MM/DD/YYYY.

7d. Material ID Code: Enter your company’s internal identification code for tracking.

7e. Material Description: Describe the specific material (for example, “4-page journal ad for Product X appearing in JAMA”).

7f. Comments: Add relevant information about how materials will be disseminated or if pieces must be used together.

Fields 8-12: Contact Information and Signature

Field 8: Applicant or agent’s return address, including country.

Fields 9a-c: Telephone number, fax number, and email address.

Field 10: Typed name and title of responsible official.

Field 11: Signature of responsible official.

Field 12: Date of signature.

Field 13: Biological Products (CBER Only)

Indicate whether the submission contains draft or final materials. This field only applies to products reviewed by CBER.

Submission Methods: eCTD vs. Paper

Since June 2021, the FDA has required electronic submission in eCTD (electronic Common Technical Document) format for Form 2253 submissions and accelerated approval presubmissions. Paper submissions are no longer accepted for these mandatory submission types.

eCTD Submission Requirements

Electronic submissions must be transmitted through the FDA’s Electronic Submissions Gateway (ESG). The submission structure follows specific requirements:

Companies must use publishing software tools to compile validated eCTD packages. Common errors that cause submission rejections include:

• Incorrect application number
• Wrong material document type code
• Issue date formatted incorrectly (must be YYYYMMDD)
• Product labeling not submitted under Section 1.14.6
• Including a cover letter when not appropriate
• Form 2253 indicating “Single Product” when multiple products are referenced

Non-Mandatory Submissions

Some submission types remain optional for eCTD format:

• Advisory comment requests
• General correspondence
• Response letters to FDA inquiries

These may be submitted through:

• eCTD via ESG
• Non-eCTD electronic format via CDER nextGen Portal
• Paper format via delivery service

Social Media and Interactive Content: Special Considerations

The rise of social media has created new challenges for Form 2253 compliance. The FDA issued guidance on interactive promotional media addressing how companies should handle dynamic online content.

What to Submit for Websites

For company-owned product websites, submit the entire static website at the time of first use. Include annotations identifying which portions are interactive and allow real-time communications (such as chat features or comment sections).

If the website remains publicly accessible, the FDA will not require submission of every subsequent update. Instead, submit a monthly listing of all sites for which the company is responsible.

What to Submit for Third-Party Platforms

For social media platforms like Facebook, Twitter, and Instagram, submit:

1. The home page of the third-party site
2. The company’s branded page or profile
3. The first promotional communication

After the initial submission, provide monthly updates listing all active sites without requiring screenshots of every individual post.

Example: Social Media Submission Timeline

Character-Limited Platforms

For platforms with character limits (like Twitter’s 280-character limit), the FDA recognizes challenges in presenting fair balance. Companies must still communicate both benefits and risks within space constraints. A link to full prescribing information does not satisfy fair balance requirements if the post itself only mentions benefits.

Real-World Enforcement Examples

Exeltis Untitled Letter (August 2023)

The FDA’s Office of Prescription Drug Promotion issued an Untitled Letter to Exeltis regarding a sponsored social media post for Slynd (drospirenone), an oral contraceptive. The violations included:

The FDA specifically noted that Exeltis “failed to submit the social media post under Form FDA-2253, which is required per 21 C.F.R. § 314.81(b)(3)(i) prior to the initial dissemination of any labeling or advertisement.”

Sprout Pharmaceuticals Warning Letter (May 2025)

The FDA issued a warning letter to Sprout Pharmaceuticals and its CEO regarding an Instagram post promoting Addyi (flibanserin). This marked the company’s second warning letter for promotional violations—they had received a previous warning in 2020 for a radio advertisement.

The Instagram post touted Addyi’s benefits but omitted critical safety information. Addyi carries a boxed warning for severe hypotension and loss of consciousness, particularly when used with alcohol. The complete absence of any risk information made the post especially problematic.

September 2025 Mass Enforcement Action

On September 9, 2025, the FDA issued over 50 untitled letters and 80 warning letters in an unprecedented enforcement action targeting direct-to-consumer pharmaceutical advertising. The letters covered promotional materials for 29 unique drugs.

Key violations cited included:

• Omission or minimization of risk information
• Unsubstantiated efficacy claims
• Fast-paced, distracting ad presentations that prevent viewer comprehension
• Failure to submit on Form FDA-2253

Eli Lilly and Novo Nordisk both received warning letters related to statements made during “An Oprah Special: Shame, Blame, and the Weight Loss Revolution.” The FDA alleged that both companies failed to submit these “promotional communications” to the FDA on Form 2253.

Penalties for Form 2253 Violations

Civil Penalties

Under Section 303 of the FD&C Act (as amended by FDAAA), companies that disseminate false or misleading direct-to-consumer advertisements face civil monetary penalties:

Untitled Letters and Warning Letters

The FDA uses a tiered enforcement approach:

Untitled Letters (Notice of Violation): These letters identify specific violations and request that the company stop the offending promotion. They represent less serious violations or first-time issues.

Warning Letters: These letters indicate more serious or repeated violations. They often require corrective advertising—companies must actively correct the misinformation they spread. Corrective advertising can be expensive and damaging to brand reputation.

Escalating Enforcement Actions

If companies fail to respond adequately to warning letters, the FDA can pursue:

• Seizure of violative products
• Injunctions preventing company operations
• Consent decrees requiring ongoing compliance monitoring
• Criminal prosecution of responsible individuals

Criminal Penalties

Misbranding violations under the FD&C Act can result in:

• Misdemeanor charges for first offenses (up to 1 year imprisonment)
• Felony charges for subsequent offenses or intentional violations (up to 3 years imprisonment)
• Individual liability for corporate officers who had authority to prevent the violation

OPDP Review Process and Timelines

Voluntary Advisory Review

Companies may voluntarily submit draft promotional materials to OPDP for advisory comments before dissemination. This is not required for most products, but it allows companies to receive FDA feedback before launching campaigns.

Core Launch Review

For new product approvals, OPDP offers a 45-day review timeline for “core launch” materials. Core launch materials include:

• One comprehensive healthcare professional labeling piece
• One healthcare professional advertisement (4 pages or fewer)
• One direct-to-consumer advertisement (4 pages or fewer)
• Professional and/or DTC product website (12 printed pages each)

OPDP implemented a 5-business-day screening period to verify that submissions meet core launch criteria before beginning the 45-day review clock.

Timeline for Core Launch Submissions:

Materials with claims not directly derived from prescribing information may require consultation with other FDA divisions, extending the review beyond 45 days.

DTC Television Advertisements

The Food and Drug Administration Amendments Act of 2007 granted FDA authority to require that DTC television spots be submitted at least 45 days before use. While this pre-dissemination submission is technically voluntary in most cases, FDA strongly recommends it for DTC TV ads.

Scenarios: When to Submit Form 2253

Scenario 1: New Print Advertisement

Maria’s pharmaceutical company creates a new 2-page journal advertisement for their FDA-approved migraine medication. The ad will appear in the March issue of a medical journal.

What Maria Should NOT Do:

• Wait until after March 1 to submit (late submission violation)
• Submit without current package insert (incomplete submission)
• Use an outdated Form 2253 version (rejection risk)

Scenario 2: Social Media Launch

James’s company wants to launch a new Instagram account to promote their dermatology product. The account will feature promotional posts about the product’s benefits for acne treatment.

What James Should NOT Do:

• Post dozens of promotional messages before first submission
• Assume social media is exempt from Form 2253
• Ignore risk information in space-limited posts

Scenario 3: Accelerated Approval Product

Dr. Chen’s company receives accelerated approval for a cancer treatment. They want to promote the product starting on launch day.

What Dr. Chen Should NOT Do:

• Wait until approval to submit launch materials (30+ day delay)
• Use any promotional material without presubmission
• Assume standard Form 2253 timing applies to accelerated approval products

Common Mistakes to Avoid

Mistake 1: Late Submission

Error: Submitting Form 2253 days or weeks after promotional materials are already in use.

Consequence: Regulatory violation of 21 CFR 314.81(b)(3)(i). The FDA can cite this as evidence of disregard for compliance. Companies have received enforcement letters specifically noting failure to submit at the time of initial publication.

Prevention: Build Form 2253 submission into your promotional material approval workflow. No material should be disseminated until the submission is complete.

Mistake 2: Incorrect Application Number

Error: Listing the wrong NDA, ANDA, or BLA number on Form 2253.

Consequence: The submission routes to the wrong product file. OPDP cannot properly track promotional activities. You may need to revise and resubmit, creating additional work and potential compliance gaps.

Prevention: Verify application numbers against FDA approval letters before each submission.

Mistake 3: Missing Product Labeling

Error: Submitting Form 2253 without the current FDA-approved prescribing information.

Consequence: Incomplete submission that may be rejected or flagged. The FDA compares promotional claims against approved labeling, so missing labeling prevents proper review.

Prevention: Include current labeling in Section 1.14.6 of every eCTD submission. For paper submissions, include two copies.

Mistake 4: Wrong Date Format

Error: Using incorrect date formatting in the eCTD submission metadata.

Consequence: Validation errors that can cause technical rejection. The correct format is YYYYMMDD (for example, 20260215 for February 15, 2026).

Prevention: Use publishing software validation tools before transmission. Verify date formats match FDA specifications.

Mistake 5: Selecting “Single Product” for Multi-Product Materials

Error: Checking “Single Product” on Form 2253 when the promotional piece mentions multiple drugs.

Consequence: Grouped submission errors. The FDA expects a Supplemental Application List identifying all referenced products with application numbers and labeling for each.

Prevention: Carefully review materials for mentions of multiple products. Corporate communications, formulary kits, and price lists commonly reference multiple products.

Mistake 6: Ignoring Social Media Requirements

Error: Assuming that social media posts are too informal to require Form 2253 submission.

Consequence: Enforcement action for failure to submit. The Exeltis Untitled Letter specifically cited a sponsored social media post that was not submitted on Form 2253.

Prevention: Treat social media as promotional labeling. Submit initial pages and posts at time of first use, then maintain monthly reporting.

Do’s and Don’ts for Form 2253 Compliance

Do’s

Do submit at the time of initial dissemination. The regulations are clear: submission timing matches dissemination timing. Build this into your promotional review process.

Do use the most current Form 2253 version. The FDA updates the form periodically. Using outdated versions can cause processing issues.

Do include annotations for interactive content. When submitting websites or social media profiles, annotate which features allow real-time user interaction.

Do separate professional and consumer materials. Submit healthcare professional materials and direct-to-consumer materials in separate submissions when possible.

Do track your submissions internally. Maintain records of all Form 2253 submissions, including confirmation of FDA receipt.

Don’ts

Don’t assume the FDA won’t notice unreported materials. The FDA monitors promotional activities through multiple channels, including trade complaints from competitors. Failure to submit stands out when the agency reviews a company’s promotional file.

Don’t include cover letters in standard 2253 submissions. Unlike other FDA submissions, routine Form 2253 filings to OPDP should not include correspondence under standard heading structures.

Don’t submit draft materials on Form 2253. Form 2253 is for final promotional materials at the time of actual use. Draft materials for advisory comment follow different procedures.

Don’t use Form 2253 for investigational drugs. Drugs under investigation cannot legally be promoted. If you’re submitting promotional materials for a product without FDA approval, you have a bigger problem than the form itself.

Don’t forget international requirements. Form 2253 applies only to U.S. submissions. Other countries have their own promotional material requirements that may differ significantly.

Understanding Related Forms and Processes

Form FDA 2567 vs. Form FDA 2253

Before 1998, CBER used Form FDA 2567 for transmitting advertising and promotional labeling for biological products. The FDA revised Form 2253 to harmonize submissions between CDER and CBER.

Today, Form 2253 serves as the standard transmittal for both drugs and biologics. Manufacturers of biological products may still use Form 2567 if they prefer, but most companies use Form 2253 for consistency.

FDA Form 2252 vs. Form 2253

Form FDA 2252 relates to annual reports on postmarketing studies, not promotional materials. Do not confuse the two forms—they serve entirely different purposes.

The Difference Between Advertising and Labeling

Under FDA regulations, “advertising” includes material in publications or broadcast through media like television, radio, and telephone systems. “Labeling” includes everything else—any written, printed, or graphic matter that accompanies or relates to the drug.

Both categories require Form 2253 submission. The distinction matters for compliance requirements:

Print advertisements need a “brief summary” containing important risk information from the labeling. Promotional labeling must be accompanied by or direct readers to the full prescribing information.

Emergency Use Authorization Products

Drugs authorized under Emergency Use Authorization (EUA) have different promotional rules than fully approved products. EUA products cannot claim to be “safe and effective” because they have not undergone the full approval review process.

For EUA products during the COVID-19 pandemic, CDER issued a Memorandum in October 2022 permitting certain promotional activities with limitations:

• Materials may describe safety and efficacy results from clinical trials summarized in authorized labeling
• Descriptions must include limitations of clinical trial data
• Materials must be submitted to FDA at least 14 days prior to initial dissemination
• Materials cannot claim the product is “safe and effective” for its authorized use

When submitting Form 2253 for EUA products, use “CDER IND” as the application type and provide the IND application number associated with the authorized EUA.

Key Entities and Their Roles

Office of Prescription Drug Promotion (OPDP)

OPDP is the primary FDA office responsible for reviewing prescription drug advertising and promotional labeling. OPDP reviewers evaluate whether promotional materials are false or misleading, provide written comments to sponsors, review complaints about alleged violations, and initiate compliance letters.

OPDP is located within CDER and receives Form 2253 submissions for prescription drugs approved under NDAs and ANDAs.

Advertising and Promotional Labeling Branch (APLB)

APLB performs similar functions for biological products within CBER. Form 2253 submissions for BLA products are typically reviewed by APLB.

Medical Legal Regulatory (MLR) Review

Within pharmaceutical companies, MLR review committees evaluate promotional materials before dissemination. MLR review involves medical, legal, and regulatory personnel who verify that claims are accurate, substantiated, and consistent with FDA-approved labeling.

While MLR review is not an FDA requirement, it represents industry best practice for ensuring promotional compliance before Form 2253 submission.

Pros and Cons of the Form 2253 System

Pros

Creates accountability: The submission requirement ensures companies document their promotional activities. This creates a paper trail that protects both the company (proving compliance) and the public (enabling FDA oversight).

Enables FDA monitoring: Without mandatory submission, the FDA would have difficulty tracking the thousands of promotional materials circulating at any time. Form 2253 provides systematic access to industry promotional practices.

Provides opportunity for internal review: The requirement to submit at time of first use encourages companies to finalize and review materials before dissemination. This “checkpoint” can catch errors before public distribution.

Harmonizes requirements: Using one form for both drugs and biologics simplifies compliance for companies with diverse portfolios.

Supports enforcement: When the FDA identifies violative promotion, the Form 2253 file provides context about what was submitted, when, and by whom.

Cons

High volume creates review challenges: With over 70,000 submissions annually containing 150,000+ materials, the FDA cannot review every submission. Many materials receive no FDA feedback until a violation is identified.

Timing requirement lacks flexibility: The “at time of initial dissemination” requirement leaves no buffer for submission delays. Companies must have perfect coordination between submission and launch dates.

Electronic submission requires technical infrastructure: eCTD compliance requires publishing software, ESG accounts, and technical expertise that can burden smaller companies.

Social media complexity: Guidance on interactive and real-time media is still evolving. Companies face uncertainty about exactly what and when to submit for dynamic online content.

No pre-approval protection: Submitting Form 2253 does not mean the FDA has approved your promotional materials. Companies can still receive warning letters for materials they properly submitted.

FAQs

Is FDA Form 2253 required for generic drugs?
Yes. Generic drug manufacturers with approved ANDAs must submit Form 2253 for all promotional materials, following the same requirements as brand-name drugs. The regulation at 21 CFR 314.81(b)(3)(i) applies to all approved prescription drug applications.

Does submitting Form 2253 mean the FDA approved my promotional materials?
No. Submission only fulfills your postmarketing reporting obligation. The FDA may review materials and issue enforcement letters even after proper submission. Submission does not indicate FDA endorsement or approval of promotional claims.

Can I submit Form 2253 after disseminating my promotional materials?
No. The regulation requires submission “at the time of initial dissemination.” Submitting late violates federal regulations and can result in enforcement action, as demonstrated in multiple OPDP warning letters.

Do I need Form 2253 for reminder advertisements?
Yes, but with fewer requirements. Reminder ads still require Form 2253 submission, though the ads themselves are exempt from including risk information if they meet reminder ad criteria. Note that reminder ads are prohibited for drugs with boxed warnings.

Is Form 2253 required for medical devices?
No. Medical devices have different promotional submission requirements through CDRH. Form 2253 applies only to drugs and biologics reviewed by CDER and CBER.

How long does the FDA keep Form 2253 submissions on file?
Indefinitely. Form 2253 submissions become part of the official application file. The FDA may reference historical submissions during inspections, enforcement actions, or policy reviews.

Do I need Form 2253 for educational materials that don’t make promotional claims?
It depends. Materials that inform without promoting specific product use may fall outside promotional labeling requirements. However, the line between educational and promotional content is narrow. When in doubt, submit.

Can I use Form 2253 for both CDER and CBER products?
Yes. Form 2253 is designed for both prescription drugs (CDER) and biological products (CBER). The form includes fields specific to biological products, such as license numbers and draft/final status.

What happens if the FDA rejects my Form 2253 submission?
You must correct and resubmit. Technical rejections typically result from validation errors in eCTD formatting. Administrative rejections may require additional documentation. Either way, you must resolve issues and resubmit to maintain compliance.

Is there a fee for submitting Form 2253?
No. The FDA does not charge submission fees for Form 2253 filings. However, companies incur costs for eCTD publishing software, ESG accounts, and staff time to prepare submissions.