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Opinion: During the Vietnam War, these physician-scientists were called ‘yellow berets.’ They are what we need to fight Covid-19
As we face off against Covid-19, we urgently need physician-scientists who can quickly translate observations…
Category: government agencies
STAT Plus: FDA cites Mylan for ‘repeated failures’ at manufacturing plants in India
For the second time in less than a year, the Food and Drug Administration has…
STAT Plus: Small vape makers seek another extension on a looming FDA application deadline, sparking battle with advocates
WASHINGTON — Vaping companies have just nine days until they must submit formal marketing applications…
Conservative operative ousted as FDA spokeswoman after just 11 days
WASHINGTON — The Trump administration removed a top Food and Drug Administration communications official from…
STAT Plus: New poll shows wide support for several Trump drug pricing reforms, but not rebate changes
WASHINGTON — Voters in several battleground states overwhelmingly support several of President Trump’s recent proposals…
The FDA’s chaotic week, Trump’s effect on science, and Musk’s big reveal
Can the Food and Drug Administration survive Trump? Are drug reviewers in the deep state?…
CDC director attempts to clarify controversial Covid-19 testing guidelines
CDC Director Robert Redfield attempted Thursday to clarify a set of controversial changes to the…
Trump has launched an all-out attack on the FDA. Will its scientific integrity survive?
WASHINGTON — President Trump has instigated an all-out crusade against the Food and Drug Administration…
New Covid-19 testing guidelines, crafted at the White House, alarm public health experts
Public health experts reacted with alarm Wednesday to new Covid-19 testing guidelines issued by the…
STAT Plus: Foundation Medicine wins FDA approval for first liquid biopsy able to detect multiple cancers
The Food and Drug Administration on Wednesday approved the first comprehensive “liquid biopsy” platform that…
As Covid-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege
WASHINGTON — Stephen Hahn, a political novice who moved here in December to take over…
Is convalescent plasma safe and effective? We answer the major questions about the Covid-19 treatment
The Food and Drug Administration is expected to issue an emergency authorization Sunday for doctors…
FDA commissioner needs to push back and tell Trump the agency is not part of the ‘deep state’
The next 73 days are going to be very difficult for Stephen Hahn. As the…
Drug makers rebut Trump tweet that FDA ‘deep state’ is delaying Covid-19 vaccines and drugs
WASHINGTON — In a tweet Saturday morning, President Donald Trump accused the Food and Drug…
Opinion: The Trump administration’s ‘public charge’ rule and Covid-19: bad policy at the worst time
As Covid-19 sweeps across the country, many immigrant communities are being hit hard by the…
STAT Plus: Drug makers seek to curtail discounts paid to hospitals as part of a controversial federal program
A growing number of drug makers are taking steps to curtail the discounts they offer…
STAT Plus: Stunning FDA rejection signals potential new hurdles for gene therapies
The Food and Drug Administration’s unexpected rejection of a gene therapy for the bleeding disorder…
STAT Plus: FDA finalizes penalties for trial sponsors that don’t share data, but critics say the effort falls short
After a year of deliberation, the Food and Drug Administration released final guidelines for penalizing…
‘A powerful shift’: Disability advocacy, once an afterthought in presidential races, gains new traction
For decades, the disability advocacy community has fought for a permanent — and prominent —…
STAT Plus: FDA’s reopening plan will keep biologics labs shuttered far longer than other government labs
WASHINGTON — The FDA is keeping its biologics labs shuttered far longer than other government…
Study finds racial bias in the government’s formula for distributing Covid-19 aid to hospitals
The federal government has systematically shortchanged communities with large Black populations in the distribution of…
Opinion: When the treatment is torture: ICE must stop using solitary confinement for Covid-19 quarantine
After months of social distancing, many of us are feeling its effects. Experts have delineated…
Opinion: Black lives depend on the U.S. dietary guidelines. Don’t water them down
Most Americans know about the Dietary Guidelines for Americans primarily through their colorful representations: the…
Ginkgo Bioworks, Mammoth Biosciences among winners of NIH’s ‘Shark Tank’ for Covid-19 tests
The National Institutes of Health selected Ginkgo Bioworks, Mammoth Biosciences, Quidel, and four other companies…
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Sanofi and GSK land $2.1 billion deal with U.S. for Covid-19 vaccine development and 100 million doses
The U.S. government’s Operation Warp Speed effort will provide up to $2.1 billion to Sanofi…
Opinion: A Covid-19 vaccine, amazingly, is close. Why am I so worried?
A mere six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists…
STAT Plus: The FDA got a lot more flexible during Covid — and pharma’s already pushing to make it permanent
WASHINGTON — The pharmaceutical industry made it clear to the Food and Drug Administration that…
STAT Plus: In unusual arrangement, deputy HHS secretary’s wife has been lobbying the agency on behalf of health care companies
WASHINGTON — Emily Hargan, who is married to Department of Health and Human Services Deputy…
STAT Plus: FDA extends deadline for stem cell clinics to comply with drug development rules
The Food and Drug Administration has pushed back by six months the deadline by which…
STAT Plus: Operation Warp Speed doesn’t have the transparency it needs
So much for transparency. In what can only be called a disappointing decision, the Trump…
NIH Director Francis Collins defends Fauci amid White House criticism
WASHINGTON — Francis Collins, the director of the National Institutes of Health, defended the beleaguered…
How HHS’s new hospital data reporting system will actually affect the U.S. Covid-19 response
WASHINGTON — It’s a fight over something as seemingly mundane as government data collection. But…
The CDC has always been an apolitical island. That’s left it defenseless against Trump
WASHINGTON — The Centers for Disease Control and Prevention, the country’s top public health agency,…
In another Covid-19 disparity, Black and Hispanic Americans are dying at younger ages than white Americans
Long after calls for more data on the disproportionate number of Covid-19 infections and deaths…
Listen: Trump’s FDA pressure, a microcosm of the pandemic, and squabbling over a vaccine
Who will stand up to the White House? How can hospitals protect workers from Covid-19?…
Opinion: A powerful law gives HHS the right to take control of remdesivir manufacturing and distribution
A rare bright spot followed the emergence of Covid-19 and its spread across the globe:…
Opinion: What to expect from ‘Modernizing the FDA’s Data Strategy’ meeting
After being called off because of the Covid-19 pandemic, the FDA’s public meeting to discuss…
Ousted federal vaccine expert alleges health secretary has continued to retaliate
WASHINGTON — Rick Bright, the ousted federal vaccine expert, amended his whistleblower complaint Thursday against…
STAT Plus: FDA urged to heighten safety warnings on common type 2 diabetes drugs
A consumer advocacy is urging the Food and Drug Administration to heighten warnings about a…
STAT Plus: The new Janet: The FDA turns to a quiet problem-solver who brings expertise — and a little controversy
WASHINGTON — Janet Woodcock, one of the FDA’s most powerful regulators, has an almost mythic…
Ignoring cancer care now may trade one public health crisis — Covid-19 — for another, NCI chief warns
Ned Sharpless is worried. The director of the National Cancer Institute believes the Covid-19 pandemic…
STAT Plus: Trump administration seeks to encourage ‘value-based’ drug pricing deals with new proposal
WASHINGTON — The Trump administration wants to revamp certain Medicaid rules about drug prices in…
STAT Plus: California attorney general says FTC failed to follow ‘best practices’ in approving AbbVie-Allergan deal
Arguing that the Federal Trade Commission did not follow “best practices” in approving AbbVie’s recent…
What does the FDA’s hydroxychloroquine decision mean for Covid-19 patients or politicians? And 4 other burning questions
WASHINGTON — The Food and Drug Administration on Monday revoked its already controversial emergency use…
STAT Plus: Telehealth is a ‘silver lining’ of the pandemic, but implementing it permanently won’t be easy
The coronavirus pandemic has stretched hospital resources beyond their capacity, disrupted the delivery of care,…
STAT Plus: The coronavirus pandemic is reigniting a fierce debate over compounded drugs
In hopes of alleviating potential drug shortages and other issues wrought by the coronavirus pandemic,…
STAT Plus: FDA finds ‘unacceptable’ levels of a possible carcinogen in a widely used diabetes pill
After months of testing, the Food and Drug Administration reported finding unacceptable levels of a…
Experts decry FDA’s halting of a high-profile Covid-19 study over approvals
Regulators at the Food and Drug Administration told STAT the agency’s decision last week to…
STAT Plus: Amid conflict-of-interest criticisms, top FDA officials recuse themselves from Covid-19 vaccine approvals
A version of this article first appeared in D.C. Diagnosis, STAT’s weekly newsletter about the…
9 ways Covid-19 may forever upend the U.S. health care industry
WASHINGTON — In the U.S. alone, Covid-19 has claimed nearly 100,000 lives and 30 million…