Sorensen drug-pricing bill draws criticism from former FDA official

(The Center Square) – U.S. Rep. Eric Sorensen, D-Illinois, is backing legislation he says would lower prescription drug costs by targeting the use of Food and Drug Administration citizen petitions

The FDA’s Rare-Disease Problem Isn’t Delay. It’s Trust.

The FDA’s recent closed-door roundtable with more than a dozen rare-disease advocacy groups hinted at a real reset after a stretch that many patients and families experienced as opaque, inconsi

Why FDA’s Plausible Mechanism Framework Matters For Ultra-Rare Disease Policy | Health Affairs...

Ultra-rare diseases often lack patient populations large enough to support randomized controlled trials. The question is not whether to abandon rigorous standards, but how to apply them when the...

The FDA Commissioner’s Job Isn’t Practicing Medicine, It’s Building Trust.

As Washington considers who should next lead the Food and Drug Administration (FDA), there will be a familiar temptation to focus on credentials. Should the Commissioner be a physician? A scientist? A

CASE Letter to Dr. Michael Waldrum, CEO of ECU Health - Hospital Facts

Retatrutide and America’s New Bootlegger Economy

Americans once associated bootlegging with bathtub gin, counterfeit liquor, and criminal syndicates exploiting Prohibition-era loopholes. Eliot Ness built his reputation chasing criminal networks that

Retatrutide and America’s New Bootlegger Economy

Americans once associated bootlegging with bathtub gin, counterfeit liquor, and criminal syndicates exploiting Prohibition-era loopholes. Eliot Ness built his reputation chasing criminal networks that

Exclusive: Inside the covert campaign to push out FDA Commissioner Marty Makary

Jilted biotechs coordinated a covert campaign with the Trump administration and Capitol Hill that helped push out FDA Commissioner Marty Makary.

The Dangerous Fantasy of Cheaper Cancer Dosing – DC Journal - InsideSources

Doctors around the world are taking risky gambles with cancer patients' lives -- as part of a well-intentioned, but misguided, attempt to reduce the cost

Toward a More Predictable, Partner-Driven FDA

The recent House Appropriations Committee’s FDA report is more than a funding document—it is a policy statement about the future of American biomedical leadership. At a time when scientifi

India seizes suspected fake Mounjaro pens, says raw materials sourced from Alibaba

Indian drug regulators seized more ​than 260 suspected counterfeit pens of Eli Lilly's obesity and diabetes drug Mounjaro ‌and said the main accused had ordered raw materials from vendors on Chinese...

FDA Decision Underscores Need for Consistent, Predictable Standards

The FDA’s decision to decline approval of Replimune’s treatment for advanced melanoma (RP1) raises important questions about the agency’s current regulatory posture and its alignment

FDA demands missing data from thousands of drugmakers | Morning in America

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Opinion | How risky can the weight-loss drug boom be? I learned the hard way.

Unregulated copycat versions of GLP-1s are a dangerous blind spot.