Drafting New or Updates for a Product’s FDA Prescribing Information

Situation

• The Label or Prescribing Information is a FDA regulated document which medical sales are restricted to when marketing a product
• The more broad the label is, the more materials and talking points are available for leveraging

Challenge

• Many drug product labels are bland and limit the adoption and patient access to novel therapies
• It is often the case that key differentiating attributes of a product were not included in the label to begin with and therefore limits the ability for commercial to speak about them

Resolution

• Since inception, Xelay Acumen has been involved with drafting 3 drug product labels that are aggressive and consistent with the Scientific Narrative/Platform as well as a comprehensive FDA negotiation strategy