DRUG SAFETY-RELATED LABELING CHANGES (SrLC) – PART I by CMK SELECT CMK SELECT CMK SELECT
CMK SELECT CMK SELECT CMK SELECT
EFFICENTLY MANAGING REVISIONS TO MARKETING MATERIALS At any time during the active marketing of a pharmaceutical product, there is a high probability of having to implement a safety label update, impacting the Important Safety Information (ISI) that is highlighted in a brand’s marketing material. Whether the label change was requested by a company to expand
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DRUG SAFETY-RELATED LABELING CHANGES (SrLC) – PART I

by CMK SELECT / /
Collaborative,Process,Of,Multicultural,Skilled,Students,During,Brainstorming,Meeting,In

Collaborative,Process,Of,Multicultural,Skilled,Students,During,Brainstorming,Meeting,InEFFICENTLY MANAGING REVISIONS TO MARKETING MATERIALS

At any time during the active marketing of a pharmaceutical product, there is a high probability of having to implement a safety label update, impacting the Important Safety Information (ISI) that is highlighted in a brand’s marketing material. Whether the label change was requested by a company to expand the data or number of indications within the current product label, or a required change that is mandated by the FDA, safety label updates are time-consuming, time-sensitive and need to be carefully managed to ensure a brand’s marketing materials are not at risk of being pulled from market use.

At CMK Select, we have extensive experience with this process and efficiently project manage label updates for our marketing clients. We have a proven 4-phase process to ensure that the brand’s priority materials remain in use and compliant with FDA guidelines.

Phase 1 (3 months prior to label approval)

  • Identify brand assets that will require updating due to the label change
  • Determine priority marketing assets
  • Confirm assets that will need to be removed from market

Phase 2 (1 week prior to label approval)

  • Confirm timing/completion date for label updates (as per internal Regulatory guidance)
  • Conduct kick-off meeting with brand, internal/external Agencies, and Legal/Medical review (LMR) teams
  • Schedule when tactics will be submitted by agencies and track in LMR review

Phase 3 (at label approval)

  • Begin execution of plan
  • Facilitate ongoing meetings with brand, agencies and LMR teams
  • Continually prioritize and track tactics through the update process
  • Notify brand and/or management of any priority items at risk

Phase 4 (post-label approval)

  • Ensure destruction notification is accurate and distributed timely
  • Obtain documentation from publishers and internal/external agencies confirming outdated material removal from third-party platforms
  • Report Key Learnings to management

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