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Technology
FDA Issues New Guidance For Use Of AI In Health Care
2021-11-17 18:49:23
by Alexa Hornbeck

WASHINGTON — The U.S. Food and Drug Administration recently partnered with Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency to issue guiding principles to align efforts and standards for artificial intelligence and machine learning medical device development... Read More

FDA Authorizes Pfizer COVID-19 Vaccine for Children 5 to 11
Health
FDA Authorizes Pfizer COVID-19 Vaccine for Children 5 to 11
2021-10-29 21:32:18
by Dan McCue

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

Health
US to Recommend COVID Vaccine Boosters at 8 Months

WASHINGTON (AP) — U.S. health experts are expected to recommend COVID-19 vaccine boosters for all Americans, regardless of age, eight months after they received their second dose of the shot, to ensure lasting protection against the coronavirus as the delta... Read More

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

Research
Audio Recordings that Reliably Detect COVID-19 not Quite Ready for Use
2021-08-11 20:43:57
by Daniel Mollenkamp

The underlying algorithms for an app that can mass detect COVID-19 through audio are not quite ready yet, researchers say. COVID-19 has a distinct effect on the audio produced by infected people, which has enticed researchers to explore using it... Read More

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

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

Health
FDA Approves Controversial Alzheimer’s Drug Despite Potential Harm
2021-06-07 19:38:35
by Reece Nations

SILVER SPRING, Md. — The Food and Drug Administration on Monday granted its approval to aducanumab, an Alzheimer’s treatment developed by Biogen for use in patients, despite mixed clinical trial results for the drug.  Prescribed under the brand name “Aduhelm,”... Read More

Federal Budget
Biden's Budget Seeks Bigger Investments And Expanded Authority For FDA
2021-06-02 19:28:23
by Daniel Mollenkamp

WASHINGTON- The Biden Administration's 2022 budget, released at the end of last week, seeks significant spending increases for the U.S. Food and Drug Administration.  The fiscal year 2022 budget request sets out $6.5 billion for the FDA, an increase of... Read More

Health
White House Steps Up Effort to Encourage COVID Shots for Adolescents
2021-05-13 11:59:00
by TWN Staff

The White House is stepping up its efforts to encourage the parents of adolescents age 12-15 to get their kids vaccinated against COVID-19.Earlier this week, the Food and Drug Administration expanded the emergency use authorization for the Pfizer BioN-Tech vaccine... Read More

Health
Parents Excited Over Prospect of Virus Shots for Children

MISSION, Kan. (AP) — After more than a year of fretting over her 13-year son with a rare liver disease, Heather Ousley broke into tears when she learned that he and millions of other youngsters could soon be eligible for... Read More

Health
Nonprescription COVID-19 Test Approved by FDA
2021-03-08 14:36:20
by Daniel Mollenkamp

WASHINGTON - The Food and Drug Administration issued an emergency authorization for a non-prescription, over the counter nostril test for coronavirus, the agency announced on Friday.  It's the first over the counter molecular test they have authorized for use without... Read More

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

Health
EXPLAINER: US Regulator Weighs in on Vaccine Dosing Debate

The first Americans vaccinated against COVID-19 are getting their second dose, while Britain has decided to postpone boosters and focus instead on giving more people a first shot — international differences that are adding to public confusion. There's growing debate... Read More

Business
Moderna Seeks Clearance for COVID-19 Vaccine After Strong Test Results

Moderna Inc. requested clearance for its coronavirus vaccine in the U.S. after a new analysis showed the vaccine was highly effective in preventing COVID-19, with no serious safety problems. A Moderna spokesman said in a text message late Monday afternoon that its application for an... Read More

Health
Doctors Tell Senate Pandemic Deaths Preventable With Early Treatments
2020-11-19 18:20:15
by Tom Ramstack

WASHINGTON -- Medical experts told a Senate committee Thursday that misguided information about early treatment contributed to giving the United States the world’s highest death rate from coronavirus. Some of them blamed the Food and Drug Administration for halting a... Read More

Health
FDA Allows 1st Rapid Virus Test That Gives Results at Home

WASHINGTON (AP) — U.S. regulators on Tuesday allowed emergency use of the first rapid coronavirus test that can be performed entirely at home and delivers results in 30 minutes. The announcement by the Food and Drug Administration represents an important... Read More

In The News
FDA Issues Draft Guidance on Cannabis Research
2020-07-22 12:43:42
by Dan McCue

WASHINGTON - The Food and Drug Administration issued a draft guidance establishing rules for lawfully researching cannabis. The guidance is limited to the development of drugs and does not cover other FDA-regulated products. Nevertheless, the release of the document and... Read More

Health
FDA Authorizes Use Of Batch Testing for COVID-19 As Labs Hit Major Delays
2020-07-20 20:17:48
by Gaspard Le Dem

The Food and Drug Administration on Friday authorized Quest Diagnostics, an American clinical laboratory, to start processing COVID-19 tests in batches in an effort to speed up testing amid a nationwide surge in coronavirus cases. The technique, called specimen pooling,... Read More

Health
FDA Issues Guidance on Development of a Safe and Effective COVID-19 Vaccine
2020-06-30 21:06:17
by Dan McCue

WASHINGTON - The U.S. Food and Drug Administration released a series of recommendations Tuesday that it say should help facilitate the timely development of a safe and effective COVID-19 vaccine. The agency said the guidance reflects advice it has been... Read More

Health
FDA Authorizes First At-Home Sample Collection Test for COVID-19
2020-04-21 20:40:19
by Dan McCue

WASHINGTON - The Food and Drug Administration Tuesday approved the first diagnostic test for the coronavirus that allows people to collect their sample at home -- a development that could greatly expand testing options in states fighting to corral the... Read More

In The News
Senators Express Frustration with FDA for Slow Response to Vaping Hazards
2019-11-15 20:38:05
by Tom Ramstack

WASHINGTON -- A Food and Drug Administration official told a U.S. Senate committee this week that new regulations to control vaping are likely coming soon, but couldn’t say when. His testimony drew rebukes and words of frustration from members of... Read More

Straight From The Well
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