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 […]
The FDA has added a Black Box warning to the popular drug montelukast (brand name Singulair). A black box warning is one of FDA’s most significant label warnings, and in this case, there are recommendations to potentially change therapeutic decisions based on the severity of the diseases and the potential risk benefit The new warning […]
Clearly, the COVID-19 pandemic has had an impact on clinical studies during drug development, and that includes in vivo bioequivalence studies. The FDA has reacted to the potential issues it sees by issuing a statement entitled Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic (here). In discussing the types of challenges that may […]
With a sense of honor and the common good, last month some scammers “promised to refrain” from attacking healthcare operations during the COVID-19 pandemic. Unfortunately, some people believed them! I get it. This virus impacts every one of us. We all would like to believe that, in this current environment, people will step up and […]
Propofol is an excellent anesthetic, relatively safe with a fast induction time and relatively quick recovery time. It is used in all types of surgical and non-surgical procedures (including intubation and time on a vent if the patient is in distress). With all the COVID 19 cases and the resultant hospitalizations and ICU stays, the […]
In early April, Contract Pharma published an article addressing what you need to know prior to submission. The author, Michelle Ryder, Principal Consultant in the Regulatory Practice of Lachman Consultants, explains “there are a few avenues FDA has opened to get to your destination of knowing what you need to know prior to submission.” How […]
The European Commission, the European Medicines Agency (EMA), and national competent authorities have recently issued an updated Question and Answers document on Regulatory Expectations for Medicinal Products for Human use during the COVID-19 Pandemic. The guidance can be found here. The guidance covers the following topics: Issues related to marketing authorizations, marketing authorizations procedures Manufacturing, […]
