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FDA Panel Votes To Recommend Johnson & Johnson’s Coronavirus Vaccine For Emergency Authorization

FDA Panel Votes To Recommend Johnson & Johnson’s Coronavirus Vaccine For Emergency Authorization

ANDREW TRUNSKY CONTRIBUTOR The Food and Drug Administration’s vaccine advisory panel voted Friday evening to recommend Johnson & Johnson’s coronavirus vaccine for emergency approval, clearing the way for its authorization, distribution and administration nationwide. The vote followed hours of the panel live-streaming its process of scouring over data from the pharmaceutical company in order to reaffirm […]

Hey, Hey, FDA! How Many Americans Have You Killed Since May?

Hey, Hey, FDA! How Many Americans Have You Killed Since May?

    by Thomas L. Knapp As I write this on December 17, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee is meeting to review a COVID-19 vaccine developed by biotech company Moderna. Likely outcome: The panel will recommend approval of the vaccine to FDA Commissioner Dr. Stephen M. Hahn. […]

FDA Grants Moderna’s Coronavirus Vaccine Emergency Authorization

FDA Grants Moderna’s Coronavirus Vaccine Emergency Authorization

ANDREW TRUNSKY CONTRIBUTOR   The FDA approved Moderna’s coronavirus vaccine for emergency use Friday, making the United States the first country to have approved two safe and effective vaccines against COVID-19. Its approval follows a key FDA panel’s overwhelming vote Thursday to endorse the vaccine’s safety and efficacy. The Moderna vaccine’s approval means that its distribution could begin […]

FDA Authorizes First Over-The-Counter Home Coronavirus Test

FDA Authorizes First Over-The-Counter Home Coronavirus Test

ANDREW TRUNSKY CONTRIBUTOR The Food and Drug Administration approved the first over-the-counter, at-home coronavirus test Tuesday. The test, developed by the Australian company Ellume Limited, is a rapid antigen test that can deliver results in approximately 20 minutes, and works on any patient older than two years of age, the FDA said in its announcement. “Today’s authorization is […]

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 […]

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