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 […]
Drs. Anthony Fauci (National Institute of Allergy and Infectious Diseases, NIH), Robert Redfield (Director, CDC), Stephen Hahn (Commissioner, FDA), and Brett Giroir (Assistant Secretary for Health, HHS) testified this morning before the Senate Committee on Health, Education, Labor, and Pensions, chaired by Senator Lamar Alexander. The goal of the hearing is to identify what went […]
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 […]
The FDA posted a Department of Justice press release discussing a temporary injunction against a Utah firm from selling and marketing silver products as a prevention and cure for the corona virus. The press release states “The Department of Justice will take swift action to protect consumers from those who would recklessly exploit this public […]
We are some three months into the worst (we hope) of the pandemic and the positive results announced of Gilead’s antiviral drug Remdesivir (which appears set to become the standard of care for COVID 19 until a vaccine is available) in a trial will likely save countless lives. The good news came from a number […]
