Food and Drug Administration News

FDA Expected to Quickly Approve Pfizer’s COVID Vaccine

The U.S. Food and Drug Administration said on Friday it was working rapidly to issue an emergency use authorization for Pfizer Inc’s COVID-19 vaccine, with the first Americans set to be immunized as early as Monday or Tuesday. U.S. Department …

U.S. Drug Advisory Panel Meets Today on Pfizer’s COVID Vaccine

A panel of outside advisers to the U.S. Food and Drug Administration is meeting on Thursday to weigh whether to recommend that the agency authorize Pfizer’s coronavirus vaccine for emergency use, one of the last steps before vaccinations could begin. …

Task of Tracking COVID-19 Vaccine Safety Falls to Multiple Federal Agencies

Monitoring Covid-19 vaccines for safety issues will fall to a group of U.S. health agencies that also will have a hand in their rollout, a potential hurdle in persuading skeptics to get the shots, say former government officials who helped …

U.S. Drug Regulator Vows Outside Review of Any COVID-19 Vaccines

The United States will need to have independent experts review COVID-19 vaccine candidates before approval, the country’s top drug regulator said on Friday, offering reassurance that his agency would not cut corners in the race to roll out a vaccine. …

FDA Medical Panel Opposes Restrictions on Breast Implants at This Time

Government medical advisers said this week it’s too soon to ban a type of breast implant that has recently been linked to a rare form of cancer, saying more information is needed to understand the problem. The Food and Drug …

FDA Vows Tougher Testing as More Manufacturers Outsource

U.S. regulators plan to revamp rules governing how medicines are manufactured, in an effort to ensure the safety of the nation’s drug supply as recalls of contaminated imports from developing countries widen. “We’ve seen a lot of instances of adulterated …

U.S. Agencies Split Over Cell Phone Cancer Risk

Two U.S. government agencies are giving conflicting interpretations of a safety study on cell phone radiation: One says it causes cancer in rats. The other says there’s no reason for people to worry. No new research was issued but last …

38 Sickened in 7 States From Tainted Eggs from Alabama

The government says 38 people in seven states have gotten sick from eggs produced by an Alabama poultry farm. The Food and Drug Administration says the illnesses are linked to salmonella-tainted eggs from Gravel Ridge Farms, which is north of …

Vermont Sues Opioid Drugmaker Over Marketing Practices

Vermont on Wednesday filed a lawsuit against drugmaker Purdue over what it called deceptive marketing of OxyContin and other prescription opioid painkillers that the attorney general says helped lead to the drug crisis in Vermont and around the country. The …

Kentucky Food Facility Suspended by FDA After E. Coli Outbreak Link

The Food and Drug Administration has suspended a Kentucky facility after it was linked to an E. coli outbreak involving a peanut butter substitute. The Kentucky Enquirer reports the FDA suspended the facility March 28 because items produced at the …