Previously in a blog post on November 21, 2016 (here) and again in a post on December 8, 2016 (here), we outlined the proposed GDUFA II program fee and the need to review the FDA spreadsheet in order to assure that affiliate firms are properly identified such that only one program fee is assessed in […]
OGD posted additional statistics relative to metrics that it routinely tracks by month. Included in these numbers are data on Refuse-to-Receive (RTR) actions, supplements received, controlled correspondence, etc. All of FY 2016 monthly RTR actions were in the double digits except for September, which saw only 9 RTR actions. Well, 2017 seems to be starting […]
The Office of Generic Drugs (OGD) has been busy in the bioequivalence arena as evidenced by its issuing of 31 new recommendations and revising 17 previously issued recommendations. The list of new and revised recommendations can be found here. As always, there are some specific recommendations that are of note while others are standard bioequivalence […]
I can’t believe another year has slipped away already. Seems like yesterday I was writing the holiday blog for 2015 and here we are again. This year brought us the renegotiations of all of the UFAs, the largest number of Generic Drug approval since the new counting system went into effect (for those of you […]
Today, FDA released a second revision to the ANDA Submissions – Refuse-to-Receive Standards, here, a holiday present to all. OGD noted that the RTR rate hovered between 10-14% over the last few years and a total of 379 ANDAs (not related to failure to pay required GDUFA fees) have been RTR-ed ANDAs during FY 2013 […]
Back in April 2016, we posted a blog regarding the potential for the FDA to remove the Black Box warning on two products indicated to help patients stop smoking based on a large clinical study that the FDA required. At that time when the studies were submitted, the Agency indicated it would review the results […]
The numbers of ANDAs that were approved, received as well as a few other of the usual early statistics for November were released yesterday and the numbers are a bit troubling. While FDA did approve a few more ANDAs in November than it did in October (which was the start of FY 2017), 59 vs […]
I usually don’t comment on political issues, but I am happy to take on this argument with zeal. While listening to the concept of FDA going back to the 1938 Federal Food, Drug and Cosmetic Act’s “safety only” approval provision over the last few weeks, I have sat quietly until my blood boiled over. I […]
On November 21, 2016 we issued an important alert (here) relative to the FDA activities regarding the proposed GDUFA II Program Fees and the responsibility of industry to review the list and provide feedback to FDA relative to its accuracy and whether there was an affiliate relationship among entities listed. This so-called “cleanup” activity […]
In a November 28, 2016 FDA response denying two Citizen Petitions (here) asking that the Agency determine that the older discontinued formulation of Protonix IV was not withdrawn for safety of efficacy reasons, the FDA said it was and provided a 7-page explanation of its reasons. They explained that when Protonix IV was first approved, […]
