FDA - search results

The Biden administration didn’t care about our epidemiology and drug safety initiatives – they just wanted us gone. This was profoundly unfortunate and has adversely affected America’s public health.

A nearly eleven-month gap between the vaccine’s discovery and FDA approval is frustrating.

“When he was a professor at Duke University, he urged major pharmaceutical companies to do larger, expensive, and often more time-consuming clinical trials in order to secure FDA certification for their new treatments.”

The U.S. Food and Drug Administration (FDA) gave the green light for the first at-home COVID-19 test that can be purchased without a doctor’s prescription, but users will have to go online to get the results.

People will soon be able to get a COVID-19 test they can administer at home and get rapid results, but they’ll need a doctor’s prescription to do so and their physician will have to submit patient information to third parties.

Physicians advocating for early at-home treatment for COVID-19 want the National Institutes of Health and the U.S. Food and Drug Administration to change their guidance on the use of hydroxychloroquine (HCQ) for early-onset COVID-19 because clinical trials on new uses for approved drugs can take years—too long for a pandemic, they argue.

“David Gortler has established himself as a sharp, out-of-the-box thinker known for his communication and teaching skills and ability to address and solve complex problems.”

The controversy surrounding the FDA’s action on convalescent plasma has drawn comparisons with how the agency, earlier in the year, first approved emergency use of HCQ to combat the coronavirus, and then withdrew the approval. 

The U.S. Food and Drug Administration (FDA) will no longer require labs to undergo a lengthy “pre-market” review of their tests, which could improve response time to public health threats, such as the COVID-19 pandemic.

Clinicians, medical researchers, statisticians, and ethicists are urging the U.S. Food and Drug Administration (FDA) to expand the use of hydroxychloroquine (HCQ) in early...