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 […]
In a rush to get serology tests out for public testing, it appears that the FDA hopped, skipped, and jumped a bit too far by not first requiring at a minimum, review of the tests and the validation of the tests through an Emergency Use Authorization (EUA) prior to them going on the market. There […]
FDA recently launched a comprehensive listing of COVID-19 related guidance documents, which can be found here. Tracking all COVID 19 related documents can be daunting, as the content is being issued at a fast and furious rate, and this website will make that task a little less onerous. The list is filterable, sortable, and can […]
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 […]
From March 31 through April 14, 2020, Lachman Consultant Services, Inc. (Lachman Consultants) conducted a voluntary survey of professionals working in the pharmaceutical, biotechnology, medical device and other sectors related to the greater life sciences industry. The purpose of the survey was to take a “pulse” of the overall organizational and industry impact of the […]
Early on Monday morning April 20, 2020, the FDA announced a relaxed policy for pharmacy compounders, if there is a shortage of certain drug products to treat COVID-19 patients that are not available through the normal supply chain or from a registered outsourcing facility. The guidance, titled Temporary Policy for Compounding of Certain Drugs for […]
On the Federal Register prepublication page (here), the FDA gives notice of the finalization of two guidance documents providing bioequivalence recommendations for two drug products that have received a lot of recent news attention, chloroquine phosphate and hydroxychloroquine sulfate. The two products have received attention because of the COVID-19 pandemic and the anecdotal reports of […]
On April 7, 2020, FDA released a Q&A on manufacturing and supply change requests related to COVID-19 and drug shortages. In this Q&A, FDA provided the following guidance: Manufacturing site changes because of supply chain disruptions related to COVID-19 – If the site change is for treatment of patients with COVID-19 or for drugs […]
The COVID-19 pandemic is sweeping the world and companies and regulators are working hard to keep up with the increased demand for drugs and devices to treat the disease. Certain products used to treat COVID-19 patients are at risk of shortage due to this increased demand. Most notably, in the EU (which is a few […]
With COVID-19 still ravaging the U.S. and the world, there are many efforts to find new treatments, find old drugs that may work, and various immunological approaches that are being evaluated to fight this disease. Just out of curiosity, I took a look at the U.S. National Library of Medicine’s Clinical Trials website (here) to […]
