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US Expected to Authorize Mix-and-Match COVID Booster Shots
Health
US Expected to Authorize Mix-and-Match COVID Booster Shots

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

FDA Panel Takes Up Tough Questions on J&J COVID-19 Boosters
Health
FDA Panel Takes Up Tough Questions on J&J COVID-19 Boosters

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

FDA Panel Endorses Lower-Dose Moderna COVID Shot for Booster
Health
FDA Panel Endorses Lower-Dose Moderna COVID Shot for Booster

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

FDA Spells Out Lower Sodium Goals for Food Industry
Food
FDA Spells Out Lower Sodium Goals for Food Industry

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

In a First, FDA Permits Marketing of E-Cigarette Products in the US
Business
In a First, FDA Permits Marketing of E-Cigarette Products in the US
2021-10-13 14:29:12
by Dan McCue

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

Next on FDA's Agenda: Booster Shots of Moderna, J&J Vaccines
Health
Next on FDA's Agenda: Booster Shots of Moderna, J&J Vaccines

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

New FDA Chief Can't Come Soon Enough for Beleaguered Agency
Regulation
New FDA Chief Can't Come Soon Enough for Beleaguered Agency

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

Pfizer Vaccine for Kids May Not Be Available Until November
Health
Pfizer Vaccine for Kids May Not Be Available Until November

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

FDA Panel Backs COVID-19 Boosters Only for Elderly, Those at High-Risk
Health
FDA Panel Backs COVID-19 Boosters Only for Elderly, Those at High-Risk
2021-09-17 20:51:48
by Dan McCue

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

FDA Experts Among Group Opposing US Booster Shot Plan
Health
FDA Experts Among Group Opposing US Booster Shot Plan

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

FDA is Taking Steps to Ensure Safe COVID-19 Vaccines for Children
Health
FDA is Taking Steps to Ensure Safe COVID-19 Vaccines for Children
2021-09-10 20:02:10
by Reece Nations

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

FDA Warns Health Care Providers of Certain N95 Respirators from China
Health
FDA Warns Health Care Providers of Certain N95 Respirators from China
2021-09-01 16:44:03
by Reece Nations

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

FDA Grants Full Approval to Pfizer-BioNTech COVID-19 Vaccine
Health
FDA Grants Full Approval to Pfizer-BioNTech COVID-19 Vaccine
2021-08-23 14:20:37
by TWN Staff

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

FDA Approves Additional COVID Vaccine Dose for Some Individuals
Health
FDA Approves Additional COVID Vaccine Dose for Some Individuals
2021-08-13 15:53:27
by TWN Staff

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

What FDA Approval Might Mean for Vaccine Mandates
Health
What FDA Approval Might Mean for Vaccine Mandates
2021-08-11 20:27:32
by Alexa Hornbeck

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

FDA Commits to Proposal to Ban Menthol Cigarettes
Health
FDA Commits to Proposal to Ban Menthol Cigarettes
2021-07-27 13:12:41
by Alexa Hornbeck

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

Dog Cancer Treatment Gets Green Light from FDA
Regulation
Dog Cancer Treatment Gets Green Light from FDA
2021-07-21 13:17:47
by Daniel Mollenkamp

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

FDA Changes Prescribing Instructions for Controversial Alzheimer’s Drug
Prescription Drugs
FDA Changes Prescribing Instructions for Controversial Alzheimer’s Drug
2021-07-08 17:38:20
by Dan McCue

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

FDA Authorizes Pfizer-BioNTech Vaccine for Emergency Use in Adolescents
Health
FDA Authorizes Pfizer-BioNTech Vaccine for Emergency Use in Adolescents
2021-05-11 15:48:23
by Alexa Hornbeck

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

FDA Expected to OK Pfizer Vaccine for Teens Within Week
Health
FDA Expected to OK Pfizer Vaccine for Teens Within Week

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

Alarming Lapses in Inspection of Drugs Made in Foreign Countries
Prescription Drugs
Alarming Lapses in Inspection of Drugs Made in Foreign Countries
2021-03-10 14:33:10
by Tom Ramstack

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

FDA Clears Single-Shot Vaccine for Use
Health
FDA Clears Single-Shot Vaccine for Use
2021-03-01 19:32:41
by Daniel Mollenkamp

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

FDA Relaxes Vaccine Storage Rules to Speed Up Rollout
Health
FDA Relaxes Vaccine Storage Rules to Speed Up Rollout
2021-02-26 21:31:46
by Daniel Mollenkamp

WASHINGTON - The Food and Drug Administration has relaxed the rules around storage and transportation for some coronavirus vaccines in order to speed up the vaccine rollout. Frozen vials of Pfizer-BioNTech's coronavirus vaccine will be allowed to be kept at... Read More

FDA Says J&J 1-Dose Shot Prevents COVID; Final Decision Soon
Health
FDA Says J&J 1-Dose Shot Prevents COVID; Final Decision Soon

WASHINGTON (AP) — Johnson & Johnson's single-dose vaccine protects against COVID-19, according to an analysis by U.S. regulators Wednesday that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic.  The Food... Read More

FDA Greenlights Record Number of Medical Devices
Health
FDA Greenlights Record Number of Medical Devices
2021-02-18 20:18:43
by Daniel Mollenkamp

WASHINGTON - In a public health milestone, the Food and Drug Administration announced on Tuesday that it approved a record setting amount of novel medical devices in 2020.  In 2020, the FDA’s Center for Devices and Radiological Health gave the... Read More

Supreme Court Allows Government to Enforce Abortion Pill Rule
Supreme Court
Supreme Court Allows Government to Enforce Abortion Pill Rule
2021-01-13 16:39:53
by Dan McCue

WASHINGTON - The U.S. Supreme Court lifted a nationwide injunction Tuesday that had prevented the federal government from enforcing a rule that required women to see a health care professional in person before she'd be given access to a so-called... Read More

2nd COVID-19 Vaccine Set for OK in US With Panel Endorsement
Health
2nd COVID-19 Vaccine Set for OK in US With Panel Endorsement

WASHINGTON (AP) — A government advisory panel endorsed a second COVID-19 vaccine Thursday, paving the way for the shot to be added to the U.S. vaccination campaign. The Food and Drug Administration is expected to follow the recommendation for the... Read More

FDA Clears First At-Home, Over-The-Counter COVID-19 Test
Health
FDA Clears First At-Home, Over-The-Counter COVID-19 Test

WASHINGTON — The first COVID-19 test that can be performed entirely from home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription. While availability initially will be limited, the new test and others in... Read More

Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review
Health
Moderna Vaccine Found Safe, Effective Ahead of Key FDA Review

Moderna Inc.’s vaccine is safe and effective for preventing COVID-19, U.S. regulators said, clearing the way for a second shot to quickly gain emergency authorization and add to the country’s sprawling immunization effort. The Food and Drug Administration’s staff said... Read More

FDA Issues Emergency Approval for Pfizer Vaccine, Others Sure to Follow
Health
FDA Issues Emergency Approval for Pfizer Vaccine, Others Sure to Follow
2020-12-11 21:19:29
by Dan McCue

WASHINGTON - Under intense pressure from the White House, the Food and Drug Administration dramatically moved up its timeline, issuing an emergency authorization for Pfizer's COVID-19 vaccine on Friday. The agency had initially planned to finalize its authorization on Saturday,... Read More

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