Category Archives: Reports

In October there were 7 new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 7 supplemental drug approvals. The FDA had acted on assignment of 3 new product reviews. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

Join RJ’s Jason Young – SVP Clinical Data Operations, Todd Cooperman – SVP Clinical Insights and Analytics, and Chris Webb – Director of Product Development, as they review the drug coding updates, revisions, and issues observed over 2019’s third quarter. Learn about: New and Existing Code Updates – HCPCS Codes: J Codes, Q Codes •  […]

Enacted in 1992, the Prescription Drug User Fee Act (PDUFA) was created to authorize the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. These fees serve as a secondary source of funding for the FDA and serve to expedite the review process.  The FDA establishes […]