Opinion: 3 steps ARPA-H needs to take to accomplish its mission
Since its formation in the 1950s, the Defense Advanced Research Projects Agency, better known as…
Category: government agencies
Opinion: The organ procurement system is failing people of color like me. It’s time for reform
I am a Black woman who has been waiting for seven years for a kidney…
Opinion: Report: U.S. nursing home care is ineffective, inefficient, inequitable, fragmented, and unsustainable
Nursing homes have been at the epicenter of the pandemic, though they have fallen off…
Tracking an FDA advisory panel meeting on Covid-19 vaccines and boosters
When the Food and Drug Administration last month announced it would be holding another meeting…
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‘All the shrapnel that’s in my back’: Defiant Robert Redfield blasts former CDC directors for criticism during Covid-19
A defiant Robert Redfield teed off on other former directors of the Centers for Disease…
NIH’s cancer chief, Ned Sharpless, to step down
Ned Sharpless, the director of the National Cancer Institute, is stepping down at the end…
STAT+: Tracking the FDA advisory panel on Amylyx Pharma’s ALS treatment
The Food and Drug Administration is convening a meeting of outside experts today to review…
CMMI’s Fowler on health policy’s ‘stubborn challenges,’ her personal ties to medicine
WASHINGTON — Liz Fowler’s career just came full circle: last March, she took charge of the…
‘A slow-moving glacier’: NIH’s sluggish and often opaque efforts to study long Covid draw patient, expert ire
WASHINGTON — The National Institutes of Health is fumbling its first efforts to study long…
NIH’s identity crisis: The pandemic and the search for a new leader leave the agency at a crossroads
WASHINGTON — Under the reign of Francis Collins, the National Institutes of Health was untouchable….
STAT+: Lawmakers face off about the future of the FDA’s accelerated approval pathway
WASHINGTON – Lawmakers are facing off over the future of the Food and Drug Administration’s…
Opinion: Commissioner Califf needs to put the F back in FDA
Robert Califf is taking the reins as commissioner of the Food and Drug Administration with…
STAT+: Congress moves toward giving FDA authority over synthetic nicotine products like Puff Bar
WASHINGTON — Lawmakers are within striking distance of closing the largest loophole in the Food…
STAT+: FDA approves second CAR-T cancer therapy to treat multiple myeloma, opening the door for greater access
The Food and Drug Administration on Monday approved a new CAR-T therapy for multiple myeloma, a…
STAT+: Ants, spiders, and mold: Why a big compounding pharmacy recently recalled all its products
Last December, a little known compounding pharmacy recalled all of its products due to “process…
Opinion: To restore public trust, the CDC must stop legitimizing the expulsion of asylum seekers
The Centers for Disease Control and Prevention has come under fire in past weeks over…
Opinion: The case for Califf: Don’t let politics prevent confirmation of best FDA commissioner candidate
President’s Biden’s nomination of Robert Califf to head the Food and Drug Administration is in…
Robert Califf is a fervent believer in data. At the FDA, will that be enough?
At his confirmation hearing last month to lead the Food and Drug Administration, Robert Califf…
STAT+: FDA’s vaccines and biologics chief talks Covid-19, 2022 priorities, and getting back to gene, cell therapy review
WASHINGTON — No part of the Food and Drug Administration has been challenged by the…
Opinion: Deaths of despair: the unrecognized tragedy of working class immiseration
Given the socioeconomic effects of the ongoing Covid-19 pandemic, it should have come as no…
Opinion: Nuclear Regulatory Commission’s foot-dragging on patient irradiation suggests regulatory capture
Government agencies responsible for protecting the public from negligence and harm must act with independence…
STAT+: 3 pharma trends to watch in 2022
As 2021 winds down, the proverbial rearview mirror displays a mix of spectacular success, vexing…
Opinion: At a time when the U.S. needed Covid-19 dialogue between scientists, Francis Collins moved to shut it down
This week, emails released through a Freedom of Information Act request filed by the American…
Top regulator says need for Omicron vaccine depends on staying power of variant
WASHINGTON — Whether Americans will need additional vaccines specifically tailored to the rapidly spreading Omicron…
STAT+: FDA rebukes Endo for ‘anticompetitive practices,’ asks FTC to investigate
In an unusual move, the U.S. Food and Drug Administration has openly suggested that a…
Califf sails through confirmation hearing for FDA job, despite tensions over opioids
WASHINGTON — Robert Califf escaped largely unscathed from a two-hour hearing Tuesday vetting him to…
Opinion: FDA’s outdated Birth Control Guide blocks access to the innovations the agency has approved
Every day, women in the United States are routinely denied access to the latest birth…
STAT+: Feeling remote: Coalition of pharma regulators look to complement on-site inspections beyond Covid
Nearly two years after the Covid-19 pandemic prompted remote inspections of pharmaceutical production plants, an…
Opinion: The U.S. is at a Kasserine Pass moment for Covid leaders
In the military, as in business and civilian life, leadership change can be needed to…
Opinion: Solving the U.S. drug pricing crisis starts with a crucial confirmation hearing
The Senate began its confirmation hearing last week for President Biden’s nominee to head the…
Opinion: Reforms needed for FDA’s regulation of medical devices
Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to…
Califf, nominee to lead FDA, asks Woodcock to stay in leadership role if he’s confirmed
WASHINGTON — Robert Califf, President Biden’s pick to lead the Food and Drug Administration, has…
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Carlos del Rio on Covid antivirals, an FDA conundrum, & the rise of Omicron
Will the first Covid-19 pill be all that useful? How worrisome is Omicron? And when…
Opinion: The Fifth Circuit Court got the science wrong on OSHA’s vaccination mandate
In mid-November, a federal judicial panel assigned the Cincinnati-based United States Court of Appeals for…
Opinion: Resident-to-resident incidents are a hidden source of harm in nursing homes. They shouldn’t be
Dwayne E. Walls was a Korean War Veteran and an investigative reporter at the Charlotte…
STAT+: FDA is urged to disqualify a hospital review board and two doctors over clinical trial missteps
The Food and Drug Administration is being urged to disqualify a Minnesota hospital and two…
STAT+: When FDA rattles its sabre, drug makers and universities start reporting overdue trial results
Over the past eight years, more than 90% of drug makers and universities that received…
Biden taps Califf to helm FDA — an agency where he has plenty of unfinished business
WASHINGTON — Robert Califf, President Biden’s new pick to lead the Food and Drug Administration,…
Listen: Moderna v. NIH, psilocybin as a medicine, & the cultural intake of pharma CEOs
Who invented Moderna’s Covid-19 vaccine? Can psychedelic medicines be mainstream? And who’s going to run…
Opinion: STAT+: Why does the FDA want to stop improving medicines via patent ‘areas of concern’?
It’s hardly unprecedented for one federal agency to encroach on another’s turf. But the latest intra-executive-branch…
Rochelle Walensky said she’d ‘fix’ the CDC, but nine months in, she’s faltering
WASHINGTON — Operating via Zoom from her home office in Newton, Mass., Rochelle Walensky is…
STAT+: New court rulings add to the confusing and controversial dispute over a U.S. drug discount program
In the latest twist in a closely watched legal battle, two different federal court judges…
Opinion: I’ve worked with Robert Califf. He is the leader the FDA needs
If the cascade of news reports are true, President Biden is finally about to name…
STAT+: The loudest physician proponents of Aduhelm have all taken money from Biogen
WASHINGTON — A small group of physicians with deep, at times undisclosed, financial ties to…
STAT+: Government’s bid to force drug makers to offer discounts to some hospitals was ‘arbitrary and capricious,’ judge rules
After more than a year of controversy, a federal court judge ruled the U.S. government…
Public-private partnership launched to accelerate gene therapies for rare diseases
The National Institutes of Health and U.S. Food and Drug Administration unveiled a public-private partnership…
FDA scientists say benefits of Pfizer Covid-19 vaccine ‘clearly outweigh’ the risks for children ages 5 to 11
Scientists at the Food and Drug Administration presented an analysis late Friday showing that the…
STAT+: FDA warns a hospital and two physicians for putting patients at ‘significantly increased’ risk in trials
In harsh tones, U.S. regulators warned a Minnesota hospital and two of its physicians for…
STAT+: Pharmalittle: Power for Medicare to negotiate drug prices grows less likely; FDA OKs mix-and-match Covid booster shots
Top of the morning to you. And a fine one it is. Crystal clear blue…
STAT+: An FDA rejection derails Omeros, exposing the empty promises of its CEO
It’s remarkable to watch Omeros CEO Greg Demopulos and his executive team dissolve into a…