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 […]
I read four articles this morning that blamed high generic and brand name prices on everything from the confusion between list price and transactional pricing (here), to too much drug regulation (here), to PBMs and to the lack of negotiations between Medicaid and drug companies (here and here). I am sure that there are many […]
Recently, the ICH has communicated the intention to develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures (here), where ultimately both documents may be combined into one document. This is welcome news as ICH Q2(R1) is long overdue for revision (current […]
With the holidays, vacations and the partial government shutdown, OGD did not do too badly, with total approval actions of 82 and still a workday to go (and there are always those pesky approvals or tentative approvals that show up after the final bell). This looks to be one of those “down months” that Cook […]
Linaclotide capsules are “minimally absorbed with negligible systemic availability following oral administration. Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation after oral doses of 145 mcg or 290 mcg were administered. Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (Cmax), and half-life (t½) […]
