FDA Explains Structured Product Labeling for REMS
The FDA recommends drugmakers implementing the structured product labeling format for risk evaluation and mitigation strategies start by assembling its experts in both areas.
In a webinar hosted Wednesday, the agency suggests that drugmakers seeking to standardize REMS via SPL rely on collaboration for submissions.
Specifically, experts in risk management should develop summaries for REMS and identify relevant data elements for those summaries. These experts should then team up with SPL specialists familiar with XML to code the summaries.