Here’s Good News, Sports Fans – Submission Dates are Back in Approval letters

Ever since I can remember, the submission date of an ANDA has been reported in the approval letter of the application.  That practice stopped in early 2016, as reported in our blog post (here). The submission dates of applications are important metrics that help the industry to track approval times for applications.   We heard a lot of complaints from industry when the approval dates disappeared.  This was even brought up by the generic trade association as contributing to a further lack of transparency in the program.

FDA blamed the change on the need for consistency in the format of approval letters with the New Drug folks.  Well, FDA did listen and I noticed that the submission date started appearing on NDA approval letters about a month ago.  I also learned that approval letters for ANDAs are also now issuing with the submission or receipt dates.  I have not seen an ANDA approval letter that contains that yet, but that is because most of the approval letters do not yet appear on the Drugs@FDA website.  Can one of our readers verify that this is occurring?  If it is, then kudos for those of you who complained and kudos to FDA for listening, as this is a very important piece of information for the industry to see.