FDA obsession with accuracy rates of Covid home-testing kits may be slowing down their availability

The United States has fallen well behind rival nations in making COVID-19 testing easily available from the comfort of your home, and regulators may be to blame. At home testing in the U.S. is still very expensive for the average American and there are few options on the market.   According to a CNN report, there … Read more

FDA seeks advice on whether to limit Covid-19 pill in pregnant people

Limiting the drug’s use to people who aren’t pregnant would prevent a significant at-risk population from accessing a treatment that likely could be prescribed for at-home use. Pregnant people with Covid may still receive monoclonal antibody treatments, but they must be administered in a health care setting. The FDA will ask advisers to consider an … Read more

FDA says Merck’s COVID-19 pill is effective and the agency will seek advice on risks during pregnancy

Federal health regulators said an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy. The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and … Read more

FDA nomination slips after Biden admin fails to send papers to Congress

But that was contingent on the administration submitting required paperwork to the committee by Nov. 19. It missed that deadline, likely pushing Califf’s confirmation vote into January. The document submission is a formality in the confirmation process, but must be completed to ensure senators have all the materials they need to fully consider a nominee. … Read more

House panel probing Covid response seeks to question former FDA chief

According to its note to Hahn, the committee appears to be interested in asking the former FDA commissioner about his time dealing with the regulatory approvals of controversial drug products, the development of the Covid-19 vaccine and the White House’s interference in the FDA’s regulatory process. Hahn did not respond to a request for comment … Read more

FDA says it might need 55 YEARS to make vaccine-related information available to the public 

The U.S. Food and Drug Administration (FDA) is requesting more than a half-century to review and release information to the Pfizer-BioNTech vaccine to the public. The agency is being sued by Public Health and Medical Professionals for Transparency, a group made up of more than 30 professors and scientists, hoping to access information they believe … Read more

FDA authorizes COVID vaccine boosters for all adults

The Food and Drug Administration moved to expand its emergency authorization of Pfizer’s and Moderna’s COVID-19 vaccine booster shots to all adults, the companies announced Friday, as health officials are clamoring to head off a potential new surge of cases this winter.  The Centers for Disease Control and Prevention must also weigh in with its recommendations … Read more

FDA clears Pfizer, Moderna Covid booster shots for all adults

Background: The agency did not convene a meeting of its independent advisory committee prior to expanding booster uses because it concluded the data submitted by both companies didn’t raise questions that would benefit from additional discussion. The agency reviewed safety concerns around the risks of a rare side effect of inflammation of the heart muscle … Read more

FDA Authorizes All-Ages Pfizer, Moderna Boosters, But These States Aren’t Waiting

Several states already have bypassed federal regulations and are offering boosters to anyone over 18 years old, even before the Food and Drug Administration Friday authorized both COVID-19 boosters from both Pfizer-BioNTech and Modern for all American adults previously vaccinated. Gov. Ned Lamont, though not issuing an executive order, earlier in the week urged Connecticut … Read more

FDA said to be ready to endorse Pfizer and Moderna boosters at once

But after Moderna filed a similar request on Wednesday, officials began debating whether to speed that authorization along as well, the people with knowledge of the matter said. The FDA declined to comment. Moderna reported earlier this summer that its booster is 93 percent effective when given six months after the second dose, and the … Read more