White House Steps Up Effort to Encourage COVID Shots for Adolescents
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

Parents Excited Over Prospect of Virus Shots for Children
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

Nonprescription COVID-19 Test Approved by FDA
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

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

EXPLAINER: US Regulator Weighs in on Vaccine Dosing Debate
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

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

Doctors Tell Senate Pandemic Deaths Preventable With Early Treatments
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

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

Poll: Most Adults Wary of Taking Any Vaccine Approved Before the Election
Opinion Polls
Poll: Most Adults Wary of Taking Any Vaccine Approved Before the Election

The public is deeply skeptical about any coronavirus vaccine approved before the November election, and only 42% would be willing to get a vaccine in that scenario, according to a new poll. The results of the poll by the Kaiser... Read More

Virus Fatigue is Risk as US Heads Into Fall, Ex-FDA Head Says
Health
Virus Fatigue is Risk as US Heads Into Fall, Ex-FDA Head Says

“Pandemic fatigue” is an additional risk as the U.S. heads into the fall and winter, when infectious diseases traditionally spread more readily, former Food and Drug Administration head Scott Gottlieb said. A coronavirus vaccine is unlikely to be available for... Read More

FDA Issues Draft Guidance on Cannabis Research
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

FDA Authorizes Use Of Batch Testing for COVID-19 As Labs Hit Major Delays
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

FDA Issues Guidance on Development of a Safe and Effective COVID-19 Vaccine
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

FDA Authorizes First At-Home Sample Collection Test for COVID-19
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

Senators Express Frustration with FDA for Slow Response to Vaping Hazards
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

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