Opinion: On Covid-19 booster shots, the FDA has overstepped its role
Booster shots for all adults six months after being vaccinated against Covid-19 are safe, effective,…
Category: government agencies
STAT+: Illuminating the black box: Five ways the FDA could build transparency into AI devices
Artificial intelligence tools in health care should be safe and effective. They should be fair…
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FDA advisory panel votes 19-0 to endorse booster dose of J&J vaccine
For an archived version of live coverage of the hearing of the FDA’s advisory panel,…
Follow the FDA advisory panel meeting on the J&J Covid vaccine booster
The booster-shot question that has been on the top of many minds for many months…
Listen: The FDA star search, more booster debates, & the future of mRNA
Are we any closer to getting a permanent FDA boss? How many Covid-19 vaccinations does…
Tracking the FDA advisory panel meeting on Moderna’s Covid vaccine booster
With people who received the Pfizer-BioNTech Covid-19 vaccine already in the process of getting booster…
FDA scientists neutral on Moderna Covid-19 vaccine booster ahead of key meeting
Food and Drug Administration scientists did not take a clear position as to whether the…
Francis Collins’ resignation could complicate the fight over funding for ARPA-H
WASHINGTON — Francis Collins’ announcement last week that he will soon step down as National…
Listen: Shkreli on film, the next NIH director, and a looming FDA deadline
Did we learn anything from the Martin Shkreli saga? Who will run the NIH? And…
NIH Director Francis Collins to step down
WASHINGTON — Francis Collins, the pioneering genetics researcher and longtime director of the National Institutes…
STAT+: The health tech tracker for the fourth quarter: the decisive industry events to watch
Winter may be coming (again), but the digital health sector remains red-hot. Fueled by fresh…
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STAT+: Appeals court rules FDA ‘arbitrarily and capriciously’ approved a rare disease drug
In a closely watched battle over regulatory decision-making, a federal appeals court ruled the U.S….
STAT+: FDA tells drug makers to redo studies run by two contract research firms due to data integrity issues
In a rare move, the U.S. Food and Drug Administration has notified an untold number…
Behind Epic’s algorithm to detect sepsis before it progresses
You’re reading the web edition of STAT Health Tech, our guide to how tech is…
Scott Gottlieb on Covid, a better CDC, and how he does it all
Former FDA commissioner Scott Gottlieb can now add published author to his long list of…
STAT+: Defense Department watchdog criticizes oversight of military’s pharmaceutical supply chain
Amid mounting concerns over the U.S. pharmaceutical supply chain, a Department of Defense watchdog found…
STAT+: Compound pharmacies win court battle over an FDA plan for monitoring shipments
A U.S. federal court judge has ruled that an effort by the Food and Drug…
Listen: Futuristic prosthetics, a treatment for ALS, & intrigue at the Holmes trial
Can prosthetic limbs feel real? Is the FDA softening under pressure? And are Rice Krispies…
Biden administration releases $25 billion in Covid relief for providers after months of delay
WASHINGTON — The Biden administration on Friday announced plans to release more than $25 billion to…
FDA misses deadline for deciding which e-cigarette products should be removed from the market
WASHINGTON — The Food and Drug Administration announced Thursday that it has failed to meet…
STAT+: For the first time, the FDA warns a trial investigator for failing to report study results
In a little noticed warning, the Food and Drug Administration threatened to fine the principal…
STAT+: The FDA has just 3 days to decide how to regulate 6.5 million e-cigarette products. But what if it blows past the deadline?
WASHINGTON — The Food and Drug Administration has just three days until it must finally…
Listen: Elizabeth Holmes on trial, FDA in disarray, & the quest for Covid antivirals
Does the Theranos trial actually matter? Is the FDA coming unglued? And what can prescription…
Opinion: Listen: A father describes the legacy of his son’s ultra-rare disease
Bertrand Might was born with a rare disease that had never before been diagnosed, an…
Opinion: STAT+: Bringing clarity and consistency to CMS’s hospital price transparency rule will be a win for all
The Centers for Medicare and Medicaid Services’ (CMS) price transparency rule requiring U.S. hospitals to…
STAT+: After company protest, FDA agrees to review controversial drug to prevent premature birth
In an unexpected turn of events, the Food and Drug Administration will hold a hearing…
A first-of-its-kind bet for an Alphabet spinout
You’re reading the web edition of STAT Health Tech, our guide to how tech is…
Opinion: A natural pandemic has been terrible. A synthetic one would be even worse
In 1988, as Russian scientist Nikolai Ustinov worked in the VECTOR lab, part of a…
Opinion: Scientific, moral imperatives underlie the ARPA-H mandate to include rare disorders
The response to Covid-19 by the biomedical research community in the U.S. and around the…
Opinion: A ‘great listening’ to patients could be a powerful legacy of the pandemic
A lasting memorial may be emerging for the millions of people who will have tragically…
Listen: Biden’s drug pricing plan, Wall Street’s Alzheimer’s fixation, & daily 5 a.m. alarms
Can drug pricing help Democrats keep the Senate? Why is there still no nominee for…
STAT+: Ellis Unger, an outspoken FDA veteran, resigns
WASHINGTON — A top FDA official known for speaking out against controversial drug approval decisions,…
Opinion: Congress should fix FDA’s accelerated approval program for the next 30 years
The Food and Drug Administration’s approval of the Alzheimer’s drug Aduhelm has sparked a broader…
STAT+: ‘We don’t unlearn’: What the pandemic has taught regulators about real-world data
During the pandemic, regulatory agencies deployed emergency measures left and right to speed care to…
STAT+: Will controversy over new Alzheimer’s drug spell the end for the FDA’s faster approval process?
WASHINGTON — For most of its history, the Food and Drug Administration’s shortcut pathway for…
STAT+: As White House mulls FDA commissioner job, a sign of industry backing for Woodcock surfaces
Shortly after the Biden administration took office, a letter-writing campaign erupted over who should be…
Billions in new research funding sparks a lobbying frenzy among patient advocates
WASHINGTON — President Biden’s vision for an ambitious new government research center is never quite…
STAT+: Athira cited altered studies in $15 million NIH grant application, creating legal risk
Biotech company Athira Pharma, which is in turmoil after its chief executive was found to…
STAT+: FDA to importer: keep your active pharma ingredients away from weed killer and antifreeze
What do weed killer, engine antifreeze coolant, dry wall repair products, and active pharmaceutical ingredients…
Opinion: Regulating digital health apps needs user-centered reform
When people seek health information, they expect what they get to be reliable and accurate….
STAT+: FDA threatens to fine another drug maker for failing to report clinical trial results
For only the second time, the Food and Drug Administration is threatening to fine a…
CDC to recommend masks indoors even for some vaccinated against Covid-19
Federal health officials will recommend Tuesday that even people who’ve had their Covid-19 shots wear…
Opinion: The first challenge for ARPA-H should be electronic health record migration
Most new, high-profile initiatives start with something splashy. President Biden’s proposed transformative biomedical agency, the…
STAT+: How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug
When the drug maker Biogen pitched its Alzheimer’s treatment to a panel of independent experts…
STAT+: FDA plans to study whether pharma reps at conference exhibit booths are telling the truth
Pandemics aside, medical conferences are popular destinations for doctors, who are barraged with information about…
STAT+: Accelerated approval, the path used to greenlight Biogen Alzheimer’s drug, has a checkered track record, critics say
If ever there were a cautionary tale for the Food and Drug Administration’s approval of…
STAT+: San Francisco, Austin, or Raleigh? White House contemplates an out-of-D.C. address for new biomedical research agency
WASHINGTON — The White House isn’t worried about Congress underfunding the new biomedical research agency…
STAT+: Atul Gawande, bureaucrat: A tough job would await the renowned surgeon at USAID
Atul Gawande has been a renowned surgeon, an award-winning magazine writer and author, a Rhodes…
Too close for comfort: FDA shouldn’t loosen conflict rules for its expert panels
Never mind the conflicts, there are drugs to approve. In a sorry turn of events,…
Listen: The FDA’s future, Biden’s tight ship, & the latest Aduhelm twist
Who’s going to run the FDA? Why isn’t the Biden administration leakier? And what if…