SPL Physician Labeling Rule Authoring

Reed Tech is teamed with Pharmiceutics Labeling Services LLC to provide pharmaceutical manufacturers with integrated services for Structured Product Labeling and Labeling Format and Content:

• Restructuring of existing “old-format” labeling into Prescribing Information with Highlights, including the drafting of Highlights and other necessary changes to labeling content
• Review of proposed labeling for content and format before filing
• Assistance in case of FDA requests to correct non-compliant proposed labeling content and/or format
• Assistance in creating Target Product Profiles and target labeling, in particular if the starting point is labeling in “old format”
• Authoring or updating U.S. labeling documents
• Authoring or updating Company Core Data Sheets (CCDS)
• Consulting and training on CCDS structure, standards for Core Safety Information, and good core labeling practices