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FDA

The FDA is the federal agency that regulates food, drugs, and other products that affect public health. It’s responsible for protecting the public from unsafe products and ensuring that products are labeled accurately. The FDA also conducts research on new drugs and medical devices.

Morning Rounds Newsletter

Politics John Wilkerson

STAT Plus: FDA official offers insights into whether gene therapy makers could use common manufacturing process

FDA provides insights into its thinking about a groundbreaking approach to making gene therapies that could help commercialize the products.

Health Helen Branswell

FDA advisory panel backs Pfizer’s RSV vaccine, but expresses some safety concerns

Politics Nicholas Florko

STAT Plus: It’s easy to buy flavored vapes in California, even in cities with longtime bans

First Opinion Guadalupe Hayes-Mota

I’m a biopharma supply chain specialist — and even I can’t find the Adderall I’m prescribed

First Opinion Emil D. Kakkis and Camille Bedrosian

Three misconceptions about the accelerated drug approval pathway

All Coverage

Politics Sarah Owermohle

STAT Plus: Federal judges question FDA authority in abortion pill hearing

Politics John Wilkerson

STAT Plus: Could an upcoming Supreme Court case make the FDA slower?

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Health Tech Casey Ross

STAT Plus: AI leaders issue a plea to Congress: Regulate us, and quickly

First Opinion Scott Brunner

STAT Plus: Compounding pharmacies offer a fix for shortages of essential drugs

Biotech Jason Mast and Adam Feuerstein

STAT Plus: FDA advisory panel narrowly recommends approval for Sarepta’s gene therapy for Duchenne

Biotech Adam Feuerstein and Jason Mast

STAT Plus: Tracking the FDA advisory panel on Sarepta’s gene therapy for Duchenne muscular dystrophy

Health Nicholas Florko

R.J. Reynolds sues California to protect ‘crisp’ cigarettes from flavor ban

The Readout LOUD Damian Garde, Meg Tirrell and Adam Feuerstein

Listen: Pharma vs. PBMs, Sarepta at the FDA, & a bold idea gone awry

Health Tech Mario Aguilar

STAT Plus: How the FDA’s pandemic flexibilities boosted mental health apps — and what happens now

Politics John Wilkerson

STAT Plus: Telework helps FDA compete for scientists. What if it’s no longer an option?

Pharmalot Ed Silverman

STAT Plus: What FDA mandate? Sun Pharma halts shipments from a plant with a troubled history

Biotech Jason Mast

STAT Plus: What to know about a pivotal FDA hearing on Sarepta’s gene therapy for Duchenne

Health Tech Lizzy Lawrence

STAT Plus: ‘Hard to catch up’: FDA commissioner on regulating new digital health tools

Health Tech Brittany Trang

STAT Plus: 4 ways the health care system should shift its thinking on AI, according to experts

The Readout LOUD Damian Garde, Meg Tirrell and Adam Feuerstein

Listen: Lilly’s Alzheimer’s success, a milestone FDA approval, & Moderna’s shrinking business

Politics Rachel Cohrs

STAT Plus: New Eli Lilly Alzheimer’s data poses Medicare coverage conundrum

Health Helen Branswell

FDA approves first RSV vaccine, a long-sought scientific achievement

Health Nicholas Florko

STAT Plus: RJ Reynolds is threatening to sue vape shops for selling flavored vapes

Health Brittany Trang

Study: Ingredient found in salad bowls and burger wrappers less safe than previously thought

Special Report Casey Ross

A research team airs the messy truth about AI in medicine — and gives hospitals a guide to fix it

Health Tech Mohana Ravindranath

STAT Plus: Telehealth companies that provide abortion pills grapple with regulatory uncertainty

Biotech Adam Feuerstein

STAT Plus: FDA approves new treatment from Biogen for rare form of ALS

Politics Rachel Cohrs

STAT Plus: Sens. Bernie Sanders, Bill Cassidy reach deal on PBM, generic reform

Pharma Nicholas Florko

STAT Plus: With little FDA oversight, melatonin supplements vary widely in actual dosage, study finds