Daily Archives: January 31, 2017

January 25, 2017: New ANDA Guidance; New Reference Standard Data Added to Orange Book

On January 25, 2017, FDA introduced an important new data update to the Orange Book . Search results and drug listings will now “clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards. Listings also indicate which products in the Discontinued Section may be referred to as an RLD. The FDA…

January 23, 2017 – FDA Cuts Federal Register Wait for Certain ANDA Approvals

According to FDAnews Drug Daily Bulletin “FDA said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Previously, the FDA would publish its findings that a drug was removed from the market for reasons other than its…