Tag Archives: FDA Approval

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 […]

The following questions were submitted by attendees during the most recent Quarterly Drug Coding, Reimbursement, and Pipeline Update Webinar for Q3 2019. or      Q:  On the “Pricing Updates” slide it shows that the majority of Code Price changes were increases, but the Medicare Allowable ASP price changes showed a majority which were decreases. Why […]

In September there was 1 new drug approval by the FDA we deemed specific to the specialty market. In addition, there were 9 supplemental drug approvals. The FDA had acted on assignment of 4 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 •  […]

In August there were 4 new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 2 supplemental drug approvals. The FDA had acted on assignment of 5 new product reviews. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

In July there were six new drug approvals by the FDA we deemed specific to the specialty market, three of the approvals were for biosimilar products. In addition, there were 2 supplemental drug approvals. The FDA had acted on assignment of eight new product reviews. Drugs included in this review are generally regarded by the […]

In June there were four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 12 supplemental drug approvals. The FDA had acted on assignment of six new product reviews. Drugs included in this review are generally regarded by the industry as specialty drugs.  Qualifiers may include anticipated […]

In May there were three new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were 14 supplemental drug approvals. The FDA had acted on assignment of three new product reviews, although no PDUFA dates were published. Drugs included in this review are generally regarded by the industry as […]

In April there were four new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were five supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for six new products for review. Drugs included in this review are generally regarded by the industry as specialty […]

In March there were three new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were four supplemental drug approvals. The FDA had acted on the assignment of new PDUFA dates for ten new products for review. Finally, there was one product that had an extension of a PDUFA […]