Pharmaceutical, biotech, and MedTech companies invest significant time and resources into developing promotional materials, only to face avoidable delays during the Medical, Legal, and Regulatory (MLR) review process. A well-prepared MLR submission not only expedites review timelines but also helps ensure compliance with evolving FDA and industry standards.
Whether you're submitting a new Healthcare Professional (HCP) campaign, patient support material, or disease awareness content, following a structured MLR submission checklist can help your team avoid rework, reduce compliance risk, and get to market faster.
Why Does MLR Readiness Matter?
MLR reviews are designed to safeguard against misleading claims, ensure fair balance and medical accuracy, and verify that materials adhere to both regulatory and legal standards and help to make materials compelling, clearly differentiated, and aligned with brand strategy. Incomplete or poor-quality materials submissions can lead to review delays, rejected content, or worse—regulatory enforcement. A practical, checklist-driven approach streamlines internal processes and sets up all stakeholders for success.
MLR Submission Checklist
A quality materials submission goes beyond a file upload. Following a clear, step-by-step guide, can help you ensure your promotional materials are complete, compliant, and ready for review. This thoughtful preparation enables MLR reviewers to assess content efficiently, reducing delays and improving the likelihood of timely approval.
Finalize Core Messaging and Claims
- All key messages are consistent with the approved product label
- Present fair balance between benefits and risks
- Integrate the approved Important Safety Information (ISI) into the material
Reference Source Documentation
- Include annotated references to support every clinical, statistical, or promotional claim
- Use FDA-approved labeling, registration studies, and primary literature
- Format all citations properly
Labeling and PI Alignment
If applicable (depending on material type):
- Annotate the material to the most current version of the Prescribing Information (PI)
- Ensure consistency with Boxed Warnings, Contraindications, Warnings & Precautions, and Adverse Events
Internal Review and Pre-MLR QC
- Conduct internal reviews for editorial accuracy, branding, and style. Confirm all comments from previous reviews have been addressed and incorporated
- Add the unique tracking number/job code and version number to the material
- Validate that all links are functional and all footnotes and visuals are correctly labeled
- Confirm that digital materials (e.g., banners, emails, landing pages) are in final format
Inclusion of Required Forms and Routing Information
- Complete the MLR submissions form with complete information.
- Provide a concise yet complete document description of the material Consider the following details:
- Who will use it (sales rep, HCP, patient, etc.)?
- What is it (print brochure, digital banner, presentation deck, etc.)?
- What’s the goal (e.g. educate, drive sales, raise awareness, etc.)?
- Where will it be used (at a congress, on a website, during a sales meeting, etc.)?
- When will it be used (Q3 launch, upcoming tradeshow, etc.)?
- Route materials to all appropriate reviewers and other key stakeholders.
Digital Assets
- For video or interactive content, including storyboards or working demos
- For websites/apps, include navigation structure, screenshots and a staging site.
- Ensure social media posts are fully mocked up to reflect what both the end user and FDA will see, including images, copy and dynamic content
- Add all required fair balance
Compliance with Regulations and FDA Guidance for Advertising and Promotion
- Comply with the Advertising and Promotion Regulations and align with the latest FDA promotional guidance (e.g., social media, Direct-to-Consumer (DTC) TV ads, reminder ads)
- Include disclaimers, limitations, and fair balance as appropriate for the medium
- For unbranded or disease awareness materials, avoid product brand colors, imagery and similar or same text
Concept Review Meeting (if needed)
- Schedule a pre-MLR meeting for high-risk or complex materials
- Address anticipated reviewer concerns upfront
- Document consensus decisions and reviewer expectations
Ensure Faster Approvals with a Streamlined MLR Submission Process
Preparing for an MLR review shouldn’t be a last-minute scramble. With proactive planning and a structured checklist, teams can increase approval speed, minimize rework, and help ensure compliant, effective promotional content.
Looking for expert support to streamline your MLR process? ProPharma's regulatory and promotional review experts can help your team optimize workflows, prepare robust submissions, and navigate even the most complex review cycles with confidence.
