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Promo Materials Review Policy

Draft FDA Promotional Review Policies in Minutes

12 minutes with CaseMark

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12 minutes with CaseMark

What you'll need

  • Product Portfolio & Labeling
  • Existing Compliance Documents
  • Organizational Structure

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Workflow

Overview

CaseMark's Promotional Materials Review Policy skill automatically drafts comprehensive internal governance policies for life sciences and pharmaceutical companies operating under FDA oversight. The AI generates a complete, structured policy covering promotional review committee composition, fair balance requirements, substantiation standards, off-label prohibitions, and audit frameworks—all aligned with current FDA regulations.

Drafting a promotional materials review policy that satisfies FDA requirements is a complex, time-intensive process requiring deep regulatory expertise. Life sciences companies must coordinate across regulatory affairs, medical affairs, legal, and marketing teams to produce policies that cover every promotional channel, material type, and compliance obligation—often taking weeks of cross-functional review.

CaseMark automates the drafting of comprehensive promotional materials review policies by analyzing your product portfolio, existing compliance documents, and organizational structure. The AI generates a complete, numbered policy document with table of contents, definitions, appendices, and regulatory citations—ready for internal review and deployment in a fraction of the time.

How it works

  1. 1. Upload your product portfolio, existing compliance documents, and organizational details

  2. 2. AI analyzes your inputs against FDA promotional regulations and industry best practices

  3. 3. Review and customize the generated policy with committee structure, procedures, and standards

  4. 4. Export the finalized policy in your preferred format (DOCX, PDF)

What you get

  • Purpose & Scope

  • Promotional Review Committee (PRC) Charter

  • Submission & Review Procedures

  • Fair Balance Requirements

  • Substantiation Standards

  • Off-Label Prohibitions

  • Recordkeeping Requirements

  • Training Program Framework

  • Monitoring & Auditing Procedures

  • Appendices (Forms, Checklists, Regulatory Citations)

What it handles

  • Structured promotional review committee charter with roles and qualifications

  • Fair balance and substantiation standards aligned with FDA regulations

  • Off-label communication prohibitions and safeguards

  • Submission and review workflow procedures

  • Recordkeeping, training, and audit framework

  • Ready-to-use appendices with submission forms and compliance checklists

Required documents

  • Product Portfolio & Labeling

    Approved product information, therapeutic areas, and current FDA-approved labeling

    .pdf, .docx

  • Existing Compliance Documents

    Current SOPs, prior FDA correspondence, warning letters, and existing promotional policies

    .pdf, .docx

  • Organizational Structure

    Details on regulatory affairs, medical affairs, legal, and marketing team structures

    .pdf, .docx, .xlsx

Supporting documents

  • Distribution Channel Overview

    Details on promotional distribution channels including digital, social media, sales force, and CME involvement

    .pdf, .docx

  • Prior Audit Reports

    Previous internal or external audit findings related to promotional compliance

    .pdf, .docx

Why teams use it

Reduce policy drafting time from weeks to minutes with AI-powered generation tailored to your organization

Ensure comprehensive FDA compliance coverage across all promotional channels and materials

Establish clear promotional review committee structures with defined roles, qualifications, and workflows

Create audit-ready documentation with built-in recordkeeping, training, and monitoring frameworks

Questions

What FDA regulations does this policy address?

CaseMark generates policies aligned with the FD&C Act and FDA promotional regulations under 21 CFR Parts 201 and 202. The output covers all major compliance areas including fair balance, substantiation, and off-label prohibitions.

Can I customize the Promotional Review Committee structure?

Absolutely. CaseMark drafts a recommended PRC structure based on your organizational details, but you can fully customize roles, qualifications, and review workflows to match your company's needs.

Does this policy cover digital and social media promotions?

Yes. CaseMark's generated policy covers all distribution channels including print, digital, social media, websites, email campaigns, trade shows, mobile apps, and CME-related materials with promotional elements.

How does this differ from a generic compliance template?

CaseMark tailors the policy to your specific product portfolio, therapeutic areas, organizational structure, and distribution channels rather than producing a one-size-fits-all template. The result is a deployment-ready policy customized to your company.

Can this policy help if we've received an FDA warning letter?

Yes. By uploading prior FDA correspondence or warning letters as part of your compliance documents, CaseMark can incorporate lessons learned and address specific regulatory concerns in the generated policy framework.

Is the output suitable for regulatory audits?

CaseMark generates audit-ready policies with comprehensive recordkeeping requirements, monitoring procedures, and documentation standards designed to withstand regulatory scrutiny from the FDA and internal compliance audits.

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