IPD Resources

Paths to Approval: Understanding U.S. Regulatory Pathways for Drug Products

This article details the potential regulatory approval pathways.

Potential Market Exclusivity Granted During U.S. Regulatory Approval Process

This article explains potential data and market exclusivity granted during the U.S. regulatory approval process.

Understanding the Process for FDA Approval and Expedited Review

This article details the FDA evaluation process and expedited review designations.

Medical Drug Coding And Reimbursement 101

This article explains medical drug coding and reimbursement.

Drug Pricing Part 2: Generic Drug Pricing

This article explains generic drug pricing, associated terms, including MAC rates and lists, biosimilar pricing, and more.

Drug Pricing Part 1: Key Terms, Stakeholders, and Brand Drug Pricing Processes

This article answers the question, "how does branded drug pricing work?" defining associated terms such as average wholesale price, wholesal