With the prevalence of COVID-19 still relatively high, with flu season upon us, and with symptoms of both infectious diseases being pretty much the same, how many of you have wondered when sick, Do I have COVID or the flu? You could always test for COVID but never had the option to home test for […]
Just think about the number of EUAs granted for at-home COVID testing. Then think of the information that is not being captured because people aren’t reporting the outcomes of all those home-administered tests. Remember the days when the number of reports of positive cases were daily headlines? Now, no one knows—or maybe it’s that so many […]
Sanitation Tunnels, as the name implies, are tunnels where a spray mist of antiseptic or disinfectant can be sprayed onto humans or animals. These tunnels, according to the FDA, were first employed in China and are being used in countries outside the United States to treat or prevent the spread of COVID‑19. The FDA further […]
FDA took action to fully approve Moderna’s Spikevax which had been the subject of an Emergency Use Authorization (EUA) since December 18, 2020. This means that the FDA has finalized its comprehensive review of the safety and efficacy of the Moderna vaccine. This is the second Covid-19 vaccine to gain full BLA approval status, the […]
Yesterday, the FDA published a document (here) detailing potential impact on the performance of specific COVID-19 detection tests for the Omicron variant as well as other variants of SARS-CoV-2. The FDA listed tests that may have reduced ability to detect the SARS-CoV-2 Omicron variant and provided a list of thirty‑three sites at which this test […]
In a prepublication Federal Register (FR) notice (here), the “Food and Drug Administration (FDA or Agency) is announcing the withdrawal of three guidance documents titled ‘Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),’ ‘Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health […]
Today, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here). This guidance responds to questions that have been asked by sponsors since the pandemic began, covers a multitude of issues, and outlines some areas of relief for applicants. Remember that the answers […]
We have all seen the FDA announcements about the use of Ivermectin, a drug approved to treat worms in humans and animals (and not to treat COVID), and you have likely seen the now infamous FDA tweet “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” Yet people are continuing […]
The FDA notes that many of the emergency use authorization (EUA) tests currently being utilized are subject to false-negative results. The FDA emphasizes (here) that variants seen in the virus may have a significant impact on COVID-19 tests and this will likely occur with greater frequency, especially as some of the variants become predominant in […]
Yesterday, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here). The guidance covers three broad areas: Generic drug product development ANDA submission and assessment and Marketing and exclusivity. The guidance offers many hints on how the Agency may deal with issues that […]
