FDA

SILVER SPRING, Md. — Watch what you eat, or at least what your food is exposed to. The Food and Drug Administration on Thursday amended its food additive regulations to no longer provide for previously authorized chemicals to be used... Read More

WASHINGTON — Members of the Senate Committee on Health, Education, Labor and Pensions wanted to know why the U.S. Food and Drug Administration is requesting nearly double its annual budget while failing to meet many of the goals tied to... Read More

WASHINGTON — Bypassing its review panel of independent experts, the Food and Drug Administration authorized a fourth dose of the Pfizer and Moderna coronavirus vaccine for people 50 and older. The authorization for the fourth shot comes as an omicron... Read More

More than half of U.S. abortions are now done with pills rather than surgery, an upward trend that spiked during the pandemic with the increase in telemedicine, a report released Thursday shows. In 2020, pills accounted for 54% of all... Read More

The U.S. Food and Drug Administration last month authorized the marketing of two combusted, filtered cigarettes as modified risk tobacco products. The products, 22nd Century Group Inc.’s “VLN (Very Low Nicotine) King” and “VLN Menthol King,” which produce all of the smoke... Read More

WASHINGTON (AP) — The Food and Drug Administration on Thursday permanently removed a major obstacle for women seeking abortion pills, eliminating a long-standing requirement that they pick up the medication in person. Millions of American women will now be able... Read More

WASHINGTON — An advisory panel for the Food and Drug Administration narrowly approved the use of a COVID-19 pill manufactured by Merck. If the agency accepts the recommendation, molnupiravir would be the first drug Americans could be prescribed and take... Read More

WASHINGTON — The Food and Drug Administration on Friday authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 to 11. “As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting... Read More

WASHINGTON (AP) — Federal regulators are expected to authorize the mixing and matching of COVID-19 booster shots this week in an effort to provide flexibility for those seeking to maintain protection against the coronavirus. The upcoming announcement by the Food... Read More

WASHINGTON (AP) — U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine and when — and whether using a competing brand for the second dose might provide better protection. The push for... Read More

U.S. health advisers said Thursday that some Americans who received Moderna's COVID-19 vaccine should get a half-dose booster to bolster protection against the virus. The panel of advisers to the Food and Drug Administration voted unanimously to recommend a booster... Read More

NEW YORK (AP) — Food companies are coming under renewed pressure to use less salt after U.S. regulators spelled out long-awaited guidelines aimed at reducing sodium levels in dozens of foods including condiments, cereals, french fries and potato chips. The... Read More

WASHINGTON  -- The Food and Drug Administration late Tuesday authorized the marketing of an electronic cigarette in the United States. A groundbreaking development in a long running debate over the healthfulness of such products. Specifically, the FDA granted the R.J.... Read More

WASHINGTON (AP) — With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it's their turn. Federal... Read More

WASHINGTON (AP) — Straining under a pandemic workload and battered by a string of public controversies, one of the leading agencies in the government's fight against COVID-19 is finally on the verge of getting a new commissioner. After nearly nine... Read More

WASHINGTON (AP) — Pfizer has submitted research to the U.S. Food and Drug Administration on the effectiveness of its COVID-19 vaccine in children but the shots may not be available until November. The company said Tuesday it provided health regulators... Read More

WASHINGTON - A Food and Drug Administration advisory panel voted unanimously Friday to recommend emergency use authorization of a booster dose of Pfizer-BioNTech COVID-19 vaccine six months after full vaccination in people 65 and older and those at high risk... Read More

The average person doesn't need a COVID-19 booster yet, an international group of scientists — including two top U.S. regulators — wrote Monday in a scientific journal. The experts reviewed studies of the vaccines' performance and concluded the shots are... Read More

WASHINGTON — With the public school year already underway around the country, the Food and Drug Administration is not taking chances when it comes to making COVID-19 vaccinations available to children younger than 12 years old. Acting FDA Commissioner Janet... Read More

WASHINGTON — The Food and Drug Administration is alerting health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co. due to “serious concerns with [their] quality.” In a letter released last week, the... Read More

WASHINGTON -- The Food and Drug Administration on Monday granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and over, making it the first to move beyond emergency use status in the United States. The approval comes as parts... Read More

The Food and Drug Administration has authorized the use of an additional dose of the Pfizer-BioNTech and Moderna COVID-19 vaccines for organ transplant recipients diagnosed as immunocompromised. Thursday’s announcement came ahead of a meeting today of the Centers for Disease... Read More

As the Delta variant continues to spread, COVID cases surge among the unvaccinated, and rates of new vaccinations decline, the U.S. Food and Drug Administration is receiving pressure from President Joe Biden to approve a COVID vaccine. Biden recently said... Read More

WASHINGTON -- The Food and Drug Administration announced they are working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars.  Menthol flavoring has been known... Read More

WASHINGTON - Dog-owners whose pets are diagnosed with a common form of cancer now have a federally approved treatment option.  That new treatment, the first fully approved drug for canine lymphoma, has shown the conditional track of animal medicine can... Read More

U.S. health regulators on Thursday approved new prescribing instructions that are likely to limit use of a controversial new Alzheimer’s drug. The announcement came through Biogen Inc., the maker of Aduhelm, which stated the update is intended to “clarify” the... Read More

WASHINGTON - The U.S. Food and Drug Administration announced Monday the Pfizer-BioNTech vaccine has been approved for emergency use for adolescents ages 12 to 15 years of age.  “Parents and guardians can rest assured that the agency undertook a rigorous... Read More

WASHINGTON (AP) — The U.S. Food and Drug Administration is expected to authorize Pfizer's COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots... Read More

WASHINGTON -- A government report released Tuesday raised alarms about the quality of pharmaceuticals made in foreign countries but consumed by Americans. It said the purity of the drugs is questionable because of a lack of adequate inspections by the... Read More

WASHINGTON - On Saturday, the Food and Drug Administration gave emergency authorization to a third coronavirus vaccine. This vaccine, unlike the Pfizer and Moderna vaccines which received emergency authorizations in December, is a single shot vaccine.  Placebo-controlled, randomized studies of... Read More