Murray, Burr Reach Deal on FDA User Fee Programs
Congress
Murray, Burr Reach Deal on FDA User Fee Programs
2022-09-27 19:19:00
by Dan McCue

WASHINGTON — Sens. Patty Murray, D-Wash., and Richard Burr, R-N.C., have struck a deal on language that will allow the reauthorization of the Food and Drug Administration’s user fee program to move forward as part of the continuing resolution Congress... Read More

Florida Sues FDA to Speed Up Canadian Drug Import Approval
Prescription Drugs
Florida Sues FDA to Speed Up Canadian Drug Import Approval
2022-09-01 20:23:26
by Tom Ramstack

TAMPA, Fla. — Florida's governor announced Wednesday his state is suing the Food and Drug Administration to speed up permission to import drugs from Canada. Canadian drugs for diabetes, hepatitis C and other common illnesses are less expensive than most... Read More

FDA Authorizes Updated COVID-19 Vaccines Targeting Omicron Subvariant
Health
FDA Authorizes Updated COVID-19 Vaccines Targeting Omicron Subvariant
2022-08-31 15:22:04
by Dan McCue

WASHINGTON — The Food and Drug Administration on Wednesday authorized updated COVID-19 booster shots specifically targeting a subvariant of omicron. The agency approved two options aimed at the BA.5 subvariant of omicron that is now dominant in the U.S.: one... Read More

Pfizer Asks FDA to Authorize COVID Booster Shots for Omicron BA.5
Health
Pfizer Asks FDA to Authorize COVID Booster Shots for Omicron BA.5
2022-08-23 17:27:53
by Dan McCue

WASHINGTON — Pfizer and its German partner, BioNTech, asked the Food and Drug Administration Monday to authorize COVID booster shots that target the omicron BA.4 and BA.5 subvariants for people aged 12 and older. The request came less than a... Read More

Nearly 5M Additional Cans of Infant Formula Soon to Reach Store Shelves
In The News
Nearly 5M Additional Cans of Infant Formula Soon to Reach Store Shelves
2022-07-08 20:37:08
by Dan McCue

WASHINGTON — More than 4.8 million cans of infant formula will be shipped to U.S. retailers from an Australian manufacturer beginning in August, the Food and Drug Administration announced Friday. The formula is being sourced from Care A2+, an Australian-owned... Read More

Federal Appeals Court Stays FDA Ban on Juul E-Cigarettes
Regulation
Federal Appeals Court Stays FDA Ban on Juul E-Cigarettes

WASHINGTON — A federal appeals court on Friday stayed the Food and Drug Administration's ban on sales of Juul Labs Inc's e-cigarettes, after the company appealed the agency's order on the grounds the ban would cause it "irreparable harm." The... Read More

FDA Says No to Juul Sales
Regulation
FDA Says No to Juul Sales
2022-06-23 20:36:23
by Eden Metzger

WASHINGTON — The Food and Drug Administration on Thursday ordered Juul Labs to pull its electronic cigarettes from the U.S. market, a move intended to curb a multibillion-dollar industry blamed for sparking a national surge in teen vaping.  "Today's action... Read More

Senate Bill Seeks Stricter Scrutiny of ‘Safe’ Chemicals in Food
Food
Senate Bill Seeks Stricter Scrutiny of ‘Safe’ Chemicals in Food
2022-05-27 16:28:49
by Dan McCue

WASHINGTON — A bill introduced by Sen. Edward Markey, D-Mass., on Thursday would tighten the rules for companies seeking pre-market approval for chemicals included in food. The legislation would also direct the secretary of the U.S. Department of Health and... Read More

Senate Releases FDA Discussion Draft With Reforms for Diagnostic Testing
Health
Senate Releases FDA Discussion Draft With Reforms for Diagnostic Testing
2022-05-18 18:36:04
by Alexa Hornbeck

WASHINGTON — Members from the Senate Health, Education, Labor and Pensions Committee released a draft of the legislative package to reauthorize user fee agreements for the U.S. Food and Drug Administration on Tuesday, which are set to end on Oct.... Read More

White House Focuses Efforts on Increasing Supply of Paxlovid
Health
White House Focuses Efforts on Increasing Supply of Paxlovid
2022-04-27 14:18:19
by Alexa Hornbeck

WASHINGTON — At a White House briefing Tuesday, Dr. Ashish Jha, the new White House Coronavirus Response Coordinator, detailed how the U.S. plans to ramp up supplies of Paxlovid, an oral antiviral treatment which is used to prevent severe illness... Read More

Murray Presses FDA to Remove Harmful Substances From Baby Food
Health
Murray Presses FDA to Remove Harmful Substances From Baby Food
2022-04-14 12:57:06
by Alexa Hornbeck

WASHINGTON — Sen. Patty Murray, D-Wash., chair of the Senate Health, Education, Labor and Pensions Committee, issued a letter this week to the U.S. Food and Drug Administration Commissioner Robert Califf, requesting the FDA step up efforts to ensure the... Read More

FDA Authorizes Second Booster Shot for Americans Over 50
Health
FDA Authorizes Second Booster Shot for Americans Over 50
2022-03-29 15:45:22
by Dan McCue

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

After Long Delay Senate Confirms Califf for FDA Chief
Political News
After Long Delay Senate Confirms Califf for FDA Chief
2022-02-15 18:24:46
by Dan McCue

WASHINGTON — The Senate on Tuesday approved Robert Califf’s nomination to be the new head of the Food and Drug Administration. The 50-46 vote came just over 12 hours after the chamber cast a decidedly narrow vote to limit debate... Read More

Drug Developer Begins Trial of Autism Treatment
Research
Drug Developer Begins Trial of Autism Treatment
2022-02-02 17:29:14
by Alexa Hornbeck

WASHINGTON — Yamo Pharmaceuticals recently enrolled its first patient in a phase 2 clinical trial that may result in medicines able to treat the core behaviors of autism spectrum disorder. “There are 20 million or more people with autism around... Read More

FDA Grants Full Approval for Moderna Vaccine
In The News
FDA Grants Full Approval for Moderna Vaccine
2022-01-31 19:11:47
by Alexa Hornbeck

WASHINGTON — The U.S. Food and Drug Administration has approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine, known as Spikevax, was approved after finding the vaccine met rigorous standards for... Read More

FDA Issues New Guidance For Use Of AI In Health Care
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

US to Recommend COVID Vaccine Boosters at 8 Months
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

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

Audio Recordings that Reliably Detect COVID-19 not Quite Ready for Use
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

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

FDA Approves Controversial Alzheimer’s Drug Despite Potential Harm
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

Biden’s Budget Seeks Bigger Investments And Expanded Authority For FDA
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

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

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