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Nov 11, 2024
A Guide to Patient Financial Assistance Programs
Patient financial assistance programs are implemented by drug manufacturers to help manage the cost of their drugs for patients.


Nov 11, 2024
Biosimilar Interchangeability: FDA Designation, Marketing Exclusivity, Guidance, and Future Trends
Biologics are regulated by the FDA and are approved under the 351(a) pathway with a Biologics License Application (BLA).


Nov 11, 2024
Understanding Limited Distribution Networks
Understanding which drugs are distributed through specialty pharmacies can be helpful for pharmacies, manufacturers, and payers


Apr 18, 2024
Introduction to Digital Therapeutics and Potential Payer Management
This article explains the ins and outs of digital therapeutics.


Dec 24, 2021
Paths to Approval: Understanding U.S. Regulatory Pathways for Drug Products
This article details the potential regulatory approval pathways.


Dec 23, 2021
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.


Dec 22, 2021
Understanding the Process for FDA Approval and Expedited Review
This article details the FDA evaluation process and expedited review designations.


Dec 16, 2021
Medical Drug Coding And Reimbursement 101
This article explains medical drug coding and reimbursement.


Dec 15, 2021
Drug Pricing Part 2: Generic Drug Pricing
This article explains generic drug pricing, associated terms, including MAC rates and lists, biosimilar pricing, and more.


Dec 14, 2021
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
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