FDA to Allow Retail Pharmacies to Offer Abortion Pills
Health
FDA to Allow Retail Pharmacies to Offer Abortion Pills
2023-01-04 15:22:54
by Dan McCue

WASHINGTON — An abortion pill previously available only from a certified doctor, clinic or two online pharmacies will soon be obtainable at local pharmacies with a prescription, the Food and Drug Administration announced Tuesday. Mifepristone is the first of two... Read More

Probe: Alzheimer’s Drug Approval ‘Rife With Irregularities’
Health
Probe: Alzheimer's Drug Approval 'Rife With Irregularities'

WASHINGTON (AP) — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA... Read More

FDA Panel Shoots Down Cytokinetics  Bid for Second Heart Drug Approval
Regulation
FDA Panel Shoots Down Cytokinetics Bid for Second Heart Drug Approval
2022-12-14 18:51:57
by TWN Staff

WASHINGTON — A panel of advisors to the Food and Drug Administration on Tuesday declined to recommend approval of a new heart drug created by biotech firm Cytokinetics, finding the benefits of the drug do not outweigh its risks. The... Read More

FDA Approves Bivalent COVID-19 Vaccines for Children as Young as 6 Months
Health
FDA Approves Bivalent COVID-19 Vaccines for Children as Young as 6 Months
2022-12-08 15:37:13
by Dan McCue

WASHINGTON — The Food and Drug Administration on Thursday amended its emergency use authorizations for the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines, saying the shots are safe to administer to children as young as 6 months old. “More children... Read More

Speedier Drug Approvals Hit Slowdown as FDA Faces Scrutiny
Health
Speedier Drug Approvals Hit Slowdown as FDA Faces Scrutiny

WASHINGTON (AP) — Expedited drug approvals slowed this year as the Food and Drug Administration's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in... Read More

FDA Conditionally Approves First Drug to Manage Acute Pancreatitis in Dogs
Regulation
FDA Conditionally Approves First Drug to Manage Acute Pancreatitis in Dogs
2022-11-17 13:50:24
by Dan McCue

WASHINGTON — The Food and Drug Administration has conditionally approved Panoquell-CA1 for the management of clinical signs associated with acute onset of pancreatitis in dogs.  Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment... Read More

FDA, Veterans Health Administration Partner to Accelerate Medical Device Innovation
Health
FDA, Veterans Health Administration Partner to Accelerate Medical Device Innovation
2022-09-28 19:27:00
by Dan McCue

WASHINGTON — The Food and Drug Administration and the Veterans Health Administration have entered into a new level of collaboration intended to help accelerate American medical device innovation.  Under the auspices of a memorandum of understanding signed last week, the... Read More

FDA Panel Backs Much-Debated ALS Drug in Rare, 2nd Review
Health
FDA Panel Backs Much-Debated ALS Drug in Rare, 2nd Review

WASHINGTON (AP) — A panel of federal health advisers voted Wednesday to recommend approval for an experimental drug to treat Lou Gehrig’s disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The... Read More

FDA Gives Millions of Americans Access to Over-the-Counter Hearing Aids
In The News
FDA Gives Millions of Americans Access to Over-the-Counter Hearing Aids
2022-08-16 14:16:55
by Dan McCue

WASHINGTON — The Food and Drug Administration issued a final rule Tuesday morning that promises to provide millions of Americans with access to lower cost, over-the-counter hearing aids. The action, which follows an executive order signed by President Joe Biden... Read More

FDA Approves COVID Vaccines for Children Aged 5 and Younger
Health
FDA Approves COVID Vaccines for Children Aged 5 and Younger
2022-06-17 15:56:33
by Dan McCue

WASHINGTON — The Food and Drug Administration on Friday gave its approval for COVID-19 vaccines for children age 5 and younger.  The shots could start as early as next week if, as expected, the Centers for Disease Control and Prevention... Read More

FDA User Fee Programs Set to See Reauthorizations but With Changes
In The News
FDA User Fee Programs Set to See Reauthorizations but With Changes
2022-06-15 20:24:06
by Alexa Hornbeck

WASHINGTON — The Senate Committee on Health, Education, Labor and Pensions voted on Tuesday to advance legislation that will reauthorize a number of important U.S. Food and Drug Administration user fee programs. “This is the most important, comprehensive FDA legislation... Read More

FDA Rebuffs Total Ban of Harmful Chemicals in Food Packaging
Food
FDA Rebuffs Total Ban of Harmful Chemicals in Food Packaging
2022-05-20 19:53:30
by Reece Nations

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

FDA Falls Short of User Fee Goals but Still Seeks Double the Budget
Health
FDA Falls Short of User Fee Goals but Still Seeks Double the Budget
2022-04-27 20:16:10
by Alexa Hornbeck

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

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

Over Half of US Abortions Now Done With Pills, Not Surgery
Women's Issues
Over Half of US Abortions Now Done With Pills, Not Surgery

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

FDA Blunders by Favoring Combustible Cigarettes Over Vastly Safer Smoke-Free Products
Opinions
FDA Blunders by Favoring Combustible Cigarettes Over Vastly Safer Smoke-Free Products

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

US Regulators Lift In-Person Restrictions on Abortion Pill
In The News
US Regulators Lift In-Person Restrictions on Abortion Pill

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

FDA Panel Narrowly Approves Merck COVID-19 Pill
Prescription Drugs
FDA Panel Narrowly Approves Merck COVID-19 Pill
2021-11-30 23:02:56
by Dan McCue

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

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 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

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