We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA envisions the pipeline of combination products moving from the typical current effort to improve the safety, efficacy or ease of use of a drug, device or biologic to a future in which combination products would pursue two or more separate therapeutic benefits.
The FDA has proposed rule changes critical to deciding which agency product center will take the lead on regulatory oversight of a particular combination product.
High-ranking company officials will be required to certify the accuracy of the data their companies submit on average sales prices (ASPs), even though the Centers for Medicare & Medicaid Services’ (CMS) long-awaited interim final rule of the Medicare Prescription Drug, Improvement and Modernization Act does little to explain how to calculate ASP.