Washington Post: FDA says at least 77 hand sanitizer products may be toxic. “Hand sanitizer demand has skyrocketed during the pandemic as Americans were urged to wash their hands often to guard against the coronavirus. That has sparked a rush of new brands onto the market. But since June, the Food and Drug Administration has identified at least 77 products — including two this week — that consumers should avoid. Many of the products’ labels say they contain ethanol (also known as ethyl alcohol) but FDA tests show that they contain methanol, or wood alcohol. Methanol can be toxic when absorbed through the skin, the agency said in an advisory, and can cause blindness. It can be lethal if ingested.”
FDA
Deseret News: You should avoid these 5 hand sanitizer brands, FDA says
Deseret News: You should avoid these 5 hand sanitizer brands, FDA says. “The Food and Drug Administration added five new brands of hand sanitizer that have tested positive for toxic chemicals. The warning comes as people continue to purchase hand sanitizer to protect themselves from COVID-19 during the coronavirus pandemic.”
Reuters: Becton Dickinson’s rapid antigen test for COVID-19 authorized by FDA, shares rise
Reuters: Becton Dickinson’s rapid antigen test for COVID-19 authorized by FDA, shares rise. “The U.S. Food and Drug Administration has granted emergency use authorization to Becton Dickinson and Co (BDX.N) for a COVID-19 antigen test that can be administered at the point of care and produce results within 15 minutes, the company said on Monday.”
Immuno-Oncology News: FDA’s New ‘Project Patient Voice’ to Share Symptoms Data From Cancer Trials
Immuno-Oncology News: FDA’s New ‘Project Patient Voice’ to Share Symptoms Data From Cancer Trials. “The U.S. Food and Drug Administration (FDA) has launched an initiative called Project Patient Voice to create a publicly available information bank describing patient-reported symptoms from cancer trials for marketed treatments. The initiative is a part of the FDA’s Oncology Center of Excellence (OCE), which is designed to advance the development and regulation of oncology products for all types of cancers.”
CBS: Federal officials allowed distribution of COVID-19 antibody tests after they knew many were flawed
CBS News: Federal officials allowed distribution of COVID-19 antibody tests after they knew many were flawed. “Federal officials failed to immediately stop the distribution of many COVID-19 antibody tests they knew were flawed, leading to inaccurate data about the spread of the virus. Congress is now investigating why the FDA did not review the tests it allowed to be distributed widely throughout the U.S.”
CNN: These 9 hand sanitizers may contain a potentially fatal ingredient, FDA warns
CNN: These 9 hand sanitizers may contain a potentially fatal ingredient, FDA warns. “The US Food and Drug Administration is advising consumers not to use hand sanitizer products manufactured by Eskbiochem SA due to the potential presence of a toxic chemical. The FDA has discovered methanol, a substance that can be toxic when absorbed through skin or ingested, in samples of Lavar Gel and CleanCare No Germ hand sanitizers, both produced by the Mexican company.”
CNN: US stockpile stuck with 63 million doses of hydroxychloroquine
CNN: US stockpile stuck with 63 million doses of hydroxychloroquine. “The federal government is stuck with 63 million doses of hydroxychloroquine now that the US Food and Drug Administration has revoked permission for the drug to be distributed to treat coronavirus patients.”
NBC News: FDA pulls emergency use authorization of hydroxychloroquine for COVID-19
NBC News: FDA pulls emergency use authorization of hydroxychloroquine for COVID-19. “The Food and Drug Administration rescinded the emergency use authorization for hydroxychloroquine to treat hospitalized COVID-19 patients on Monday, saying the drug carries too many risks without any apparent benefit. The authorization was first issued in March, and applied to patients hospitalized with the illness and those in clinical trials. In April, the FDA warned doctors against prescribing the drug to COVID-19 patients outside of those settings. Monday’s action will not affect clinical trials, which are expected to continue.”
BuzzFeed News: Internal FDA Documents Show How Little Evidence The Agency Had Before Allowing Malaria Drugs To Be Used To Treat COVID-19
BuzzFeed News: Internal FDA Documents Show How Little Evidence The Agency Had Before Allowing Malaria Drugs To Be Used To Treat COVID-19. “The Food and Drug Administration authorized two malaria drugs boosted by President Donald Trump to treat COVID-19 in March based on threadbare evidence, according to an agency review obtained by BuzzFeed News through a Freedom of Information Act lawsuit. The review also raised serious questions about shoddy practices at overseas factories that manufactured and donated the drugs for use in American hospitals, according to the documents.”
CNN: Inside the FDA’s reversals and walk-backs as it grapples with the coronavirus pandemic
CNN: Inside the FDA’s reversals and walk-backs as it grapples with the coronavirus pandemic. “Whether due to political pressure — a charge [Dr. Stephen]Hahn denies — or the natural burden of dealing with a global pandemic, the FDA has had to issue a number of high-profile walk-backs and revisions to its efforts to tackle Covid-19. The agency’s initially strict regulations for diagnostic test developers were removed after complaints. Its emergency authorization for hydroxychloroquine was followed by a sharp warning about deadly side effects. It issued a pullback after letting faulty antibody tests flood the market. In April it changed its guidance to allow the use of Chinese-made KN95 masks in healthcare settings, only to reverse course in May and ban many of them. There were even issues with the FDA-authorized test the White House used to screen visitors.”
Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens (FDA)
FDA: Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens. “Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. Specifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory developed test (LDT), which had been previously added to the high complexity molecular-based LDT ‘umbrella’ EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.”
Washington Post: Dozens of coronavirus antibody tests on the market were never vetted by the FDA, leading to accuracy concerns
Washington Post: Dozens of coronavirus antibody tests on the market were never vetted by the FDA, leading to accuracy concerns. “The Food and Drug Administration, criticized for slowness in authorizing tests to detect coronavirus infections, has taken a strikingly different approach to antibody tests, allowing more than 90 on the market without prior review, including some that are being marketed fraudulently and are of dubious quality, according to testing experts and the agency itself.”
TechCrunch: FDA debuts new online portal to encourage donation of plasma from recovered COVID-19 patients
TechCrunch: FDA debuts new online portal to encourage donation of plasma from recovered COVID-19 patients. “One of the avenues currently being pursued in terms of developing an effective treatment for COVID-19 is through the use of convalescent plasma. Basically, that means using the liquid component of blood from people who have had, and already recovered fully from, COVID-19 to produce treatments that hopefully translate to others the antibodies they developed over the course of fighting off the virus. The FDA has created a dedicated new website seeking recovered COVID-19 donations, and explaining its potential uses.”
Slashgear: That 2-minute coronavirus test FDA approval was a “misunderstanding”
Slashgear: That 2-minute coronavirus test FDA approval was a “misunderstanding”. “After claiming they’d received FDA authorization for a 2-minute coronavirus antibody test earlier this week, a company called Bodysphere just changed their tune. They made clear in their press release released at the tail end of March, 2020, that the Food and Drug Administration had approved their coronavirus (COVID-19) testing kit. It all seemed too good to be true. Turns out, it was.”
Regulatory Focus: FDA Launches Searchable Purple Book
Regulatory Focus: FDA Launches Searchable Purple Book. “The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product information, known as the Purple Book. Building off the previous PDF lists of biological products, the database now allows for easier searches and includes information on product names (proprietary and proper), the type of biologics license application (BLA) that was submitted, strength of the biologic, dosage form, product presentation, license status, BLA number and approval date.” I didn’t know how a “biological product” was defined. I got educated via this FDA PDF.
