A panel of experts voted to recommend that the Food and Drug Administration authorize a booster dose of the Johnson & Johnson COVID vaccine at least two months after the first shot.
The FDA has issued new targets to reduce the amount of salt that manufacturers put in their foods. It could prevent thousands of cases of cardiovascular disease.
Johnson & Johnson has asked the Food and Drug Administration to authorize a booster for people 18 and older six months after initial immunization, with an option to vaccinate after two months.
The Food and Drug Administration released briefing documents Tuesday on booster shots for the Moderna and Johnson & Johnson COVID vaccines ahead of a two-day advisory meeting that starts Thursday.
Dr. Janet Woodcock, an administrative veteran of the Food and Drug Administration since the 1980s, has been acting director of the agency since January. Why is the permanent job so hard to fill?
The leaders of two federal health agencies are telling White House COVID-19 advisers that there is not enough data right now to make a blanket recommendation on boosters.
Moderna submitted data from 344 volunteers who got a third shot of the vaccine six months after their first two doses. The additional shot significantly boosted immunity, the company said.
Using the COVID vaccine "off-label" — whether that's for booster shots or young children — may be tempting to some vaccine providers, but the CDC warns it could get them into trouble.
The FDA announced the Pfizer vaccine is the first in the U.S. that is now fully approved. Here's what that means for vaccine mandates and convincing vaccine-hesitant people to get vaccinated.
More than 130 dogs died, 220 were sickened, and Midwestern Pet Food had inadequate food safety practices, the agency says. The company has recalled several products.
The FDA has expanded a nationwide recall of shrimp products from Avanti Frozen Foods sold at major retailers. So far, nine people in four states have contracted salmonella; three were hospitalized.
The FDA amended its emergency use authorizations for the Pfizer and Moderna vaccines to allow for an additional dose for some immunocompromised people.
In a U.S. House subcommittee meeting Wednesday, Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, agreed that “any flavor of e-cigarette left on the market is likely to encourage youth to start vaping” and that “if FDA banned all flavored e-cigarettes, less kids would continue to vape.”
The FDA is in the process of determining which, if any, e-cigarette manufacturers will be permitted to stay on the market.
In his resignation letter, Dr. Aaron Kesselheim calls it "probably the worst drug approval decision in recent U.S. history." An FDA official says the agency found the benefits outweighed the risks.
