STAT+: FDA report details problems at Global Pharma plant involved in eye drop recall
Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed…
Category: FDA
STAT+: FDA proposes a new plan to streamline updates to medical devices that use AI
The Food and Drug Administration on Thursday released a new plan allowing developers of medical…
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Opinion: To deal with the next pandemic, the FDA needs an Office of Preparedness and Response
New evidence of the spillover of the avian flu virus, known as H5N1, to some…
New lupus partnership with FDA aims to end drug trials’ history of failure
Lupus is a disease long-plagued by failed clinical trials. And hopeful patients, many of them…
FDA approves over-the-counter Narcan. Here’s what it means
The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing…
STAT+: Medical device companies now need to prove to FDA they’re protected against cyber attacks
Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors…
STAT+: Under protest, FDA to convene advisory panel to review controversial cell therapy for ALS
The Food and Drug Administration will convene a meeting of independent advisers to review a…
Listen: Bancel v. Bernie, Sarepta’s FDA runaround, & Regeneron’s ever-growing blockbuster
What would Jonas Salk say if he were here right now? How do you know…
STAT+: Top FDA official: Agency needs to start using accelerated approval for gene therapies
DALLAS — A top Food and Drug Administration official said Monday that the agency needs…
STAT+: Pharmalittle: Sanofi cuts price on a popular insulin by 78%; Califf criticizes insurers for doing too little on drug research
And so, another working week will soon draw to a close. Not a moment too…
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STAT+: Califf criticizes insurers for doing too little on drug research
WASHINGTON — FDA Commissioner Robert Califf wants private insurers to chip in on doing post-approval…
STAT+: Momentum grows to subject medical devices to medicine’s gold standard — the placebo treatment
It’s the gold standard in medicine: taking a treatment, and putting it head-to-head against a…
STAT+: FDA approves first treatment for Rett syndrome, a genetic neurological disease
The Food and Drug Administration on Friday approved the first treatment for Rett syndrome, a…
Listen: Robert Califf on how drugs get approved, plus the nascent revolution in obesity
What keeps the FDA commissioner up at night? How will Ozempic change the world? And…
STAT+: Biden makes drug pricing a central part of his deficit reduction plans
WASHINGTON – President Biden made lowering drug prices a key part of his budget with…
‘Truth is losing the battle’: FDA commissioner on grappling with a wave of health misinformation
The Food and Drug Administration is considering whether it needs to revamp guidance on how…
FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt
Last week, the Food and Drug Administration issued an emergency authorization for the first at-home…
Becerra: Judge set to rule on abortion pill is ‘beginning to read the law’
WASHINGTON — Health secretary Xavier Becerra on Tuesday warned of dramatic consequences if a federal…
STAT+: Controversial drug for premature birth is withdrawn by manufacturer after battle with FDA
After months of anticipation, the manufacturer of a controversial drug for premature births has agreed…
Opinion: The FDA is the right agency to regulate CBD products, but it needs help
The dietary supplement industry has been begging for federal oversight of products containing cannabidiol (CBD),…
STAT+: FDA may not always require post-approval trials to be enrolled before accelerated approvals
WASHINGTON — A Food and Drug Administration official on Monday gave more clues for how…
FDA eases rules again for gay men seeking to donate blood
WASHINGTON (AP) — The U.S. is moving to ease restrictions on blood donations from gay…
It’s easy to buy flavored vapes in California, even in cities with longtime bans
LOS ANGELES – California cities are supposed to be cracking down on sales of flavored…
After nearly 4 years of deliberation, FDA punts on how to regulate CBD
WASHINGTON — The FDA is giving up on trying to figure out a way to…
STAT+: The 4 biggest questions about the FDA’s forthcoming changes to accelerated approvals
WASHINGTON — Congress just boosted the FDA’s authority over the post-market clinical trials that are…
‘Hot mess’: Abortion pills at pharmacies could face legal quagmires, especially in restrictive states
WASHINGTON — Federal regulators’ green light for pharmacists to dispense abortion pills is crashing into…
STAT+: Still hoping for looser FDA rules, Regeneron says it will test durable antibody for Covid
SAN FRANCISCO — For months, drugmakers have been pleading with regulators to lower the bar…
STAT+: FDA’s Califf says congressional report on Aduhelm controversy contained “no surprises”
SAN FRANCISCO – U.S. Food and Drug Administration commissioner Robert Califf doesn’t disagree with the…
Opinion: Four types of bias in medical AI are running under the FDA’s radar
Although artificial intelligence is entering health care with great promise, clinical AI tools are prone…
‘It’s taken longer than I thought’: A former FDA commissioner on the loosened restrictions on abortion pills
When the Food and Drug Administration lifted some — but not all — of its…
Listen: #JPM23, the future of Alzheimer’s, & rising Covid variants
What does 2023 have in store for biotech? How can the FDA win back trust?…
Priorities pile up for HHS, FDA, CMS, NIH, and other health agencies
WASHINGTON — The nation’s health agencies already have a long to-do list for 2023. Top…
Opinion: The Aduhelm Operetta: ‘I’ve got a little list’
The Congressional report on the FDA’s approval of Aduhelm makes some good points. As regulatory…
FDA, Biogen, and an Alzheimer’s drug approval: 8 key takeaways from congressional investigation
Congressional investigators sorted through more than 500,000 pages of documents from the Food and Drug…
STAT+: ‘Rife with irregularities’: Congressional investigation reveals FDA’s approval of Aduhelm marked by secret discussions, breaches of protocol
WASHINGTON — The Food and Drug Administration’s review and approval of a controversial Alzheimer’s drug…
New FDA guidance explains that Plan B is not an abortion pill
The Food and Drug Administration on Friday altered the language attached to emergency contraceptive pills…
STAT+: McDonald’s adds targets for limiting antibiotic use in beef to its menu, but doesn’t say when
After being accused of backtracking on a commitment to reduce its use of medically important…
Pharma wins changes in bill regarding FDA’s accelerated approval
A bill that makes it easier for the Food and Drug Administration to withdraw drugs…
STAT+: Drugmakers ask regulators to change standards on new Covid antibody drugs for most vulnerable
Biotech executives and a handful of academics pleaded with U.S. and European regulators on Thursday…
STAT+: Amid fears of superbugs, sales of antibiotics used in food-producing livestock barely declined last year
Amid fears of superbugs, the sale of medically important antibiotics given to food-producing livestock declined…
STAT+: Congress has a chance to close the FDA’s Theranos loophole
WASHINGTON – Theranos, and the company’s notoriously inaccurate blood tests, could potentially have been stopped…
STAT+: FDA chief calls agency’s food program ‘under-supported, under-resourced’
FDA Commissioner Robert Califf said the food side of the agency needs more attention Wednesday,…
Opinion: Congress needs to update FDA’s ability to regulate diagnostic tests, cosmetics
Congress is considering two measures that modernize tools the Food and Drug Administration uses to…
FDA approves first microbiome drug from Ferring Pharmaceuticals
The Food and Drug Administration approved the first therapy using bacteria from stool samples to…
Resistance to FDA’s opioid-disposal plan raises concerns about CADCA, a powerful advocacy group
At its surface, it seems like a simple problem with a simple solution. Across the…
STAT+: FDA approves a gene therapy for the inherited bleeding disorder hemophilia B
The Food and Drug Administration on Tuesday approved the first gene therapy to treat people…
STAT+: GSK to withdraw blood cancer drug from U.S. market following confirmatory study setback
British pharma giant GSK said Tuesday that it will withdraw its blood cancer drug Blenrep…
STAT+: Pharmalittle: Type 1 diabetes drug is priced at $194,000; abortion opponents sue FDA over abortion pill approval
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
To gin up opposition to the proposed menthol ban, tobacco companies are turning to gas station ads
GETTYSBURG, Pa. — At the Gateway mini mart here, you can buy menthol-flavored hemp cigarettes,…
The FDA has banned certain vapes and medicines. We still bought these 13 products in its backyard
WHITE OAK, Md. — The Food and Drug Administration, as the name suggests, is supposed…