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 The FDA made these modifications to reflect recent clarifications published in the draft guidance for industry” entitled Referencing Approved Drug Products in ANDA Submissions.  Click here for the full story, or here to contact us for help with your ANDA submission.