Today, in the Federal Register pre-publication notice (here), “the Food and Drug Administration (FDA or Agency) is announcing the availability of draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran (2-MTHF), cyclopentyl methyl ether (CPME), and tert-butyl alcohol (TBA).” The recommendations are based on the testing parameters established for developing permitted […]
Most of the diagnostic tests that are currently being marketed for detecting COVID-19 are subject to emergency use authorizations (EUAs). Today, the FDA published a listing of commercial manufacturers of serological tests who had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have […]
Sports fans, are you deprived of watching real time live sporting events? The German teams have started up in the Bundesliga again. But I have a better idea! How about watching the race to approvals that the Office of Generic Drugs is running? Posting their approval action for April today shows that they are running […]
In a move that has me puzzled, the Government’s award of the contract to a company that does not appear on the FDA’s list of DMF holders, and is not found as a holder of any approved ANDA or NDA in the FDA’s Orange Book seems a bit strange. According to a FOX news story […]
A recent court case and FDA win (here) provides the backdrop for a peek at some of the risks of a 505(b)(2) NDA applicant seeking to gain approval for an abuse deterrent opioid formulation or product. The basic issue, from a layman’s perspective, is that a firm submitted an NDA (likely a 505(b)(2) application) for […]
The Office of Generic Drugs updated its March 2020 statistics today (here) with few surprises. As they say on American Idol, when giving the results, “dim the lights and here we go.” The OGD again refused to receive only three ANDAs in March and all three were for standard review ANDAs. There were sixty-three ANDAs […]
We all know that the most expensive prescription is the one the patient does not take. Certainly, there are several factors that impact the decision for a patient to fill a prescription. Failure to comply with medication directions can also impact the health of the patient. These failures to comply can lead to more expensive […]
Looking over the daily COVID-19 updates from the FDA (here), I noticed that the OGD had approved “two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation: succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL.” Glad to see that […]
The FDA has sent a “Dear Colleague” letter (here) to NDA holders to get ready for the start of FY 2021 on October 1, when the program fees (previously called “product fees” in previous iterations of PDUFA) will be due for each product (up to 5 in each application) marketed by the application holder. The […]
Based on the FDA All Approval List (here, search for April), it appears that the Office of Generic Drugs had a banner month with 65 full approval actions and 22 tentative approval actions, for a total of 85 approval actions for the month. Of course, these are preliminary numbers, as OGD will not likely publish […]
