Opinion: The FDA in the 2020s: move forward, don’t stand still
Federal regulatory agencies can’t stand still. They must evolve with industries they regulate. No agency…
Category: government agencies
STAT Plus: An FDA program to ensure decades-old drugs finally get approved is costing billions in price hikes
Back in 2006, the FDA launched an effort to force drug companies to win regulatory…
STAT Plus: Gilead loses another challenge to a pair of U.S. patents for an HIV prevention pill
For the second time this month, Gilead Sciences (GILD) has lost a bid to invalidate…
STAT Plus: FDA names genes that may interact with specific drugs, offering clarity to genetic testing industry
The burgeoning industry built around telling patients how their genes may interact with specific drugs…
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STAT Plus: Lawmakers to Trump: Don’t give ‘monopolies’ to companies that develop coronavirus treatments with taxpayer funds
Nearly four dozen lawmakers asked the White House to ensure any treatment for the fast-moving…
STAT Plus: New life for an old battle: Trump plan to remove tobacco regulation from FDA draws fire
An earlier version of this story first appeared in D.C. Diagnosis, STAT’s weekly newsletter about the…
Trump doesn’t want the FDA to regulate tobacco
The Trump administration is proposing to strip the Food and Drug Administration of all authority…
STAT Plus: Pharma execs argue new Canadian regulations for setting drug prices will hurt the country
As Canada gets set to implement new regulations designed to cut prescription drug spending, the…
Watch: Top FDA official talks bringing the agency into a new age
When Dr. Amy Abernethy arrived at the Food and Drug Administration last year, the former…
STAT Plus: FDA and FTC vow to attack anti-competitive practices that limit biosimilar uptake
As frustration mounts over the slower-than-expected uptake of biosimilars in the marketplace, two U.S. federal…
U.S. to quarantine all U.S. citizens evacuated from Wuhan, as CDC raises pandemic possibility
U.S. health officials said Friday they would forcibly quarantine 195 U.S. citizens who were evacuated…
STAT Plus: European regulators could take a harder line on the review of an Agios blood cancer drug
A European regulatory setback for a Bristol-Myers Squibb (BMY) blood-cancer drug could have a negative…
STAT Plus: Trump’s Medicaid changes offers states new powers to lower drug costs — with a catch
WASHINGTON — The Trump administration on Thursday unveiled a powerful new tool for states to…
A coronavirus ‘czar?’ Trump took the opposite course: a 12-member committee
WASHINGTON — President Obama had an Ebola “czar.’’ George W. Bush and Clinton had AIDS…
STAT Plus: U.S. officials will let Novartis pay expenses for some Kymriah patients who must travel for treatment
In an unexpected move, the Department of Health and Human Services will allow Novartis (NVS)…
STAT Plus: Most innovative cancer drugs take too long to reach patients in the U.K.
Despite giddy advances in treating cancer, a new analysis finds needed medicines have been reaching…
STAT Plus: With new rules, FDA aims to spark competition, lower prices for expensive gene therapies
WASHINGTON — The Food and Drug Administration released a slew of gene therapy policies Tuesday…
Federal officials tell China: Let U.S. health workers enter to help respond to coronavirus
WASHINGTON — Federal officials on Tuesday called for a team of Americans to be allowed…
He once sent untrue, alarmist tweets about Ebola. Now, Trump is facing his biggest outbreak emergency — and experts are worried
WASHINGTON — When Ebola was spreading in West Africa in 2014, Donald Trump took to…
STAT Plus: Another patient charity settles charges it helped drug makers pay Medicare kickbacks
After a contentious, two-year battle with federal authorities, a patient charity called Patient Services agreed…
STAT Plus: What does the latest twist in the Sarepta saga mean for the future of the FDA? We discuss
Earlier this week, the Food and Drug Administration released documents that reveal a schism within…
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WHO postpones decision on whether to declare China outbreak a global public health emergency
The World Health Organization on Wednesday delayed a decision on whether to declare the ongoing…
STAT Plus: European court upholds controversial EMA transparency rules for clinical trial data
After months of anticipation, the European Court of Justice has sided with the European Medicines…
STAT Plus: Airing frustrations with pharma, a Republican FTC commissioner just endorsed Medicare negotiation
WASHINGTON — A Republican member of the Federal Trade Commission on Thursday expressed support for…
FDA and NIH let clinical trial sponsors keep results secret, investigation shows
This story was originally published by Science. It is a follow-up to STAT articles in…
Opinion: What roulette and basketball can teach Biogen about aducanumab
Say that one day you see me walk up to a roulette table and win…
STAT Plus: Bristol-Myers and Sanofi accuse Hawaii of violating their free speech rights
In an unusual move, two of the world’s biggest drug makers — Bristol-Myers Squibb (BMY)…
Trump touted a new antidepressant as a solution for veterans. Only 15 have been treated
In August, President Trump proudly proclaimed that he had directed the Department of Veterans Affairs…
Trump plan to curb teen vaping exempts some flavors
WASHINGTON — U.S. health officials will ban most flavored e-cigarettes popular with underage teenagers, but…
STAT Plus: Most Americans misunderstand approvals and FDA’s role in overseeing drug ads
The Food and Drug Administration may be a high-profile government agency, but a new survey…
2019 was supposed to be the year Washington lowered drug prices. What happened?
WASHINGTON — Lawmakers of all stripes made an agreement the day following the midterm elections…
STAT Plus: One drug maker has a lot more to lose than others, under early drafts of drug importation plans
WASHINGTON — President Trump’s plan to let states and drug wholesalers import medicines from Canada…
STAT Plus: GAO finds ongoing problems with FDA inspections of foreign drug facilities
Amid rising concern over the quality of the pharmaceutical supply chain, a government report finds…
Opinion: The EPA’s proposed ‘transparency rule’ will harm health, safety, and the environment
A proposed rule by the Environmental Protection Agency (EPA) that allegedly aims to strengthen transparency…
STAT Plus: Lawmakers ask HHS for greater oversight of patient assistance programs
Amid ongoing concern about the use of patient assistance programs by the pharmaceutical industry, two…
Opinion: Cutting 700,000 Americans from SNAP will increase health costs
The Supplemental Nutrition Assistance Program (SNAP) is our nation’s first line of defense against food…
Families are reeling after FDA rejects therapy for kids born without a thymus gland
When Charlie Luckesen turned 2 the Wednesday before Thanksgiving, his family celebrated with a golden…
STAT Plus: What side effects? Problems with medicines may be vastly underreported to the FDA
It’s no secret that the many side effects caused by medicines do not get reported…
STAT Plus: Pharmalittle: China to bulk-buy to lower drug costs; Senate bill to tackle drug prices going nowhere fast
Good morning, everyone, an welcome to another working week. We hope the weekend respite, which…
Why the huge surge in EEE cases? Federal rules requiring quick sample disposal mean we may never know
A massive surge in human cases of Eastern equine encephalitis this autumn has raised urgent…
New CDC report offers a possible clue about why vaping illnesses sprang up in 2019
A new report adds to the evidence that vitamin E acetate might play a role…
Some brain-boosting supplements contain an unapproved drug that could harm users, study warns
Promising to lift brain fog or improve memory, brain-boosting supplements have joined sexual-enhancement and weight-loss…
Stephen Hahn, Trump’s FDA nominee, pledges ‘bold action’ on vaping but sidesteps questions on flavor ban
WASHINGTON — President Trump’s nominee to lead the Food and Drug Administration, faced with a…