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Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested. The […]

FDA: Deregulating During the Pandemic, and Beyond

FDA: Deregulating During the Pandemic, and Beyond

    By Dvorah A. Richman The press has obsessively focused on supposed government shortfalls regarding COVID-19 testing. However, virtually no attention has been given to the Food and Drug Administration’s (FDA’s) vigorous and unprecedented efforts to ease regulatory requirements during the pandemic. One such effort involves “immediately in effect” enforcement policies for medical devices that […]

FDA Approves First Antibody Test for COVID-19

FDA Approves First Antibody Test for COVID-19

BY ZACHARY STIEBER The Food and Drug Administration (FDA) approved the first blood test for seeing if patients were infected with COVID-19 in the past but have since recovered, a key component of many plans looking at restarting the U.S. economy amid the pandemic. Dr. Stephen Hahn, commissioner of the administration, announced the approval during an interview […]

FDA: All Versions of Heartburn Drug Zantac Should Be Removed From Market Immediately

FDA: All Versions of Heartburn Drug Zantac Should Be Removed From Market Immediately

BY ZACHARY STIEBER Zantac, a heartburn drug, should be immediately removed from the market, the Food and Drug Administration (FDA) said on Wednesday. Manufactures should withdraw all versions of the drug because the agency has determined an impurity, N-nitrosodimethylamine (NDMA), in some of them increases over time, potentially resulting in unacceptable levels of the impurity. “We didn’t […]

COVID-19 Tests: The Non-fake News

COVID-19 Tests: The Non-fake News

  By Dvorah Richman   Federal officials recently testified before the U.S. House Committee on Oversight and Reform about government responses to the COVID-19 crisis. Committee members exhibited concern and frustration, and engaged in politicized finger-pointing, over what they said was needlessly slow development and distribution of diagnostic tests – particularly as compared to some […]

FDA Approves Coronavirus Test That Can Provide Results In 45 Minutes

FDA Approves Coronavirus Test That Can Provide Results In 45 Minutes

CHUCK ROSS INVESTIGATIVE REPORTER . The Food and Drug Administration (FDA) approved the use of a coronavirus test that can detect the virus within 45 minutes, the company that makes the tests announced on Saturday. The FDA approved the test, created by Cepheid, a California-based medical device company, through Emergency Use Authorization, a process the helps […]

FDA Keeping Watch for Potential Medical Supply Shortages Amid COVID-19 Outbreak

FDA Keeping Watch for Potential Medical Supply Shortages Amid COVID-19 Outbreak

BY ZACHARY STIEBER   The U.S. Food and Drug Administration is monitoring the medical product supply for potential disruptions caused by the new coronavirus outbreak amid a “chronic shortage” of some supplies. Medical supplies like masks are already running low in some areas of the country in addition to a shortage globally amid a sharp spike in demand. Stephen Hahn, […]

FDA: Enforce Rules Against False and Misleading Claims

FDA: Enforce Rules Against False and Misleading Claims

  By Paul Driessen A couple years ago, the US Food and Drug Administration sent a “Warning Letter” to Nashoba Brook Bakery, advising its owners that listing “love” as an ingredient in their granola violated the Food, Drug and Cosmetic Act. The product was “misbranded,” because “love” is “not a common or usual name of […]

Happy Belated Halloween

Happy Belated Halloween

    By Mr. R President Trump was kind enough to hand out candy to children for the upcoming Holiday of Halloween, the same as many stores, business and people in U.S. would be doing. But let’s take a long look at this. Let’s stand back and think about what this candy is really about. […]

FDA Takes Steps Toward Cheaper Epipen Generics | But Americans Still Struggle to Pay for Expensive Prescription Drugs

FDA Takes Steps Toward Cheaper Epipen Generics | But Americans Still Struggle to Pay for Expensive Prescription Drugs

Evie Fordham | Contributor The Food and Drug Administration (FDA) authorized a generic version of EpiPen Thursday in response to the drug’s ballooning price as the agency continues to incentivize the pharmaceutical industry to make generics to reduce drug prices. American drug company Mylan manufactures the anti-allergic reaction product, which can cost up to $600 […]

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