The unprecedented length of the government shutdown has a lot of people scratching their heads about lots of things. From a personal perspective, I have heard that FDAers are still getting paid (Commissioned Corps and civil servants) but the unknown is, for how long? When will the user fee money really run out? Has FDA […]
It will only be weeks until the User Fee carryover money for all the User Fee programs runs out. While Commissioner Gottlieb is doing his best to shuffle resources, the Agency will likely be up the perpetual tributary without any physical means of propulsion soon. Because the Agency cannot accept any new fee-paying applications since […]
I woke up this morning to some sad news. Bob West, former Public Health Service officer who spent some 40+ years in government service, passed away yesterday. For those of you in the drug industry, the name Bob West meant a caring, rational, helpful individual. Bob came to OGD after a stint with the Public […]
In an unusual move, the FDA posted a guidance document on its webpage describing how to handle tentative approvals titled “ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs” (here) prior to its announcement in the Federal Register with this accompanying note: “We are posting this document on the FDA website […]
The Office of Generic Drugs (OGD) has taken great pride in meeting all of its GDUFA goals (including most, if not all, ANDA review goal dates). But, Houston, we may have a problem! Here are some facts that may have the OGD worrying into the future: December is typically one of the largest months for […]
OGD fully approved 69 original ANDAs and tentatively approved 31 for a total approval action of 100. This is actually 18 more than we were able to spot on the FDA all approvals actions in our January 3rd post (here). Not bad, considering the short month with vacations and the Federal government shutdown that started […]
Shortly after the 1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman) was passed (the legislation that greatly expanded the universe for generic drug products), and even before the first generic under the new legislation was passed, a campaign was initiated to undermine the public’s confidence in generic drugs. Major pharmaceutical companies began petitioning […]
Attempts to access the Federal Register sites, where many of the pre-publications for important FDA business, regulatory actions, proposed and final rules and regulations, petitions and the like are published is met with the following notice: Due to the shutdown of the Federal Government, National Archives facilities are closed, websites and social media are not […]
In 2018, the FDA says it approved fifty-nine new molecular entities, which included a whopping thirteen biosimilar products. All of the NME product approvals can be found here. It is important for you the read the FDA explanation of how the Agency is defining NMEs for the purposes of this report and stay focused on […]
Despite the shutdown, it appears that the OGD is still pumping out ANDAs and updating required statistical metrics as it chugs along under what must be stressful conditions. November 2018 (Month 2 of FY 2019) showed just four ANDAs received refuse-to-receive actions (four for standard ANDAs and one for a priority ANDA. The OGD acknowledged […]
