Promotional and Medical Material Review

Regulatory Oversight and the Role of Medical Review

The FDA, through the Center for Drug Evaluation and Research (CDER), establishes comprehensive regulations for the pharmaceutical industry covering all aspects of drug development and marketing for products in the United States. To enforce these regulations, the Office of Prescription Drug Promotion is tasked with ensuring that accurate, fair, balanced, and non-misleading information is presented in Prescribing Information and medical or promotional advertising materials.

As part of the medical, legal, and regulatory (MLR) review process for medical and promotional materials, reviewers must critically evaluate content in written, audio, and video materials for accuracy and compliance with regulatory requirements. Medical reviewers verify that all data and claims about the drug have substantial evidence from FDA-reviewed clinical trials supporting them. Specifically, medical review of materials involves taking an in-depth look at values and data points reported in clinical trials to ensure accuracy and consistency across both promotional and non-promotional medical materials. Another critically important goal of medical review is to ensure that all efficacy claims are balanced with appropriate safety information. Achieving the optimal balance between regulatory compliance and effective communication of product information in medical and promotional materials requires expertise and a strategic approach—something our experienced review services deliver consistently.

Medical Review Services Backed by Scientific Expertise

Our Scientific Content team brings extensive experience in collaborating with pharmaceutical clients across diverse therapeutic areas, ensuring reviewed materials meet compliance standards while remaining comprehensive and engaging. We can serve as your subject matter experts, providing strategic day-to-day oversight of medical and promotional materials review and operational activities. We review materials with meticulous attention to detail, ensuring they meet all regulatory requirements and support patient safety.

Medical and Promotional Review Service Options

Med Communications has many years of experience supporting clients with medical and promotional review services. Our review services are classified into three categories that can be tailored to fit your company’s unique needs.

• General reference review, approval, and formatting: Our team can help support your company and agency partner’s content creation and update activities for medical and promotional materials by reviewing, vetting, and formatting newly added references. This will ensure that the most current references, obtained from high-quality, reputable sources, are presented in all materials according to your standards.
• Medical quality assurance (QA)/fact check review: Our medical reviewers can actively engage in the MLR review cycle for your projects and focus on the intricately detailed task of fact-checking data points alongside references to ensure accuracy and consistency across all materials. This approach streamlines your MLR review process, improving both efficiency and resource allocation while maintaining the highest quality standards.
• Dedicated medical reviewer: Our dedicated medical reviewer can be seamlessly integrated into your medical team, providing leadership and strategic input for planning and support for all operational activities associated with the medical and promotional materials review process.

Partner With Med Communications for Medical Review Support

Med Communications can partner with you and provide dependable review services for promotional and medical materials of your drug products. Contact us to discuss how our review services can support your specific regulatory and medical communication requirements.

Frequently Asked Questions

What does a medical reviewer do?

A medical reviewer checks every claim, data point, and reference in your promotional or medical materials. They confirm the science is correct, balanced with safety information, and presented in clear, FDA-compliant language.

What does a medical review involve?

The process usually includes five steps:

1. Collect the draft material and all cited references.
2. Verify each statistic, quote, and graphic against the original source.
3. Add or adjust safety language so benefits and risks stay balanced.
4. Check formatting and readability for FDA and company style rules.
5. Send a clean, track-changed file back to the team for final approval.

Why do pharmaceutical companies need medical and promotional material review?

FDA regulations require drug information to be truthful, balanced, and not misleading. A formal medical, legal, and regulatory (MLR) review catches errors early, reduces the risk of warning letters, and helps protect patient safety.

How long does an MLR review usually take?

Timelines vary with project size, but most reference checks take three to five business days. A full MLR cycle for complex campaigns can span five to 10 business days. We also offer expedited reviews when timelines are tight.

What types of materials can Med Communications review?

We review prescribing information, journal ads, sales aids, websites, social posts, videos, podcasts, slide decks, booth graphics, and internal training pieces. If it mentions your product, we can review it.