STAT

FEBRUARY 3, 2024

Documents released this week shed new light on an aggressive strategy from vape maker Juul to court Black leaders, including the Rev. Al Sharpton, to publicly support its e-cigarettes. It’s not clear how much the company ultimately spent on the partnerships. Continue to STAT+ to read the full story…

Documentation 145

Documentation 145

The FDA Law Blog

APRIL 21, 2025

By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process.

Documentation 64

Documentation FDA 64

STAT

APRIL 24, 2024

HCA Healthcare, the largest for-profit hospital chain in the United States, is planning to expand the use of an artificial intelligence tool to document doctor-patient interactions in its emergency rooms.

Documentation 138

Documentation Hospitals 138

STAT

JANUARY 18, 2024

Microsoft on Thursday said it will launch its artificial intelligence tool for automating clinical documentation within health records software made by Epic, a move to embed the technology in health systems nationwide.

Documentation 139

Documentation Hospitals 139

STAT

NOVEMBER 15, 2022

However, a STAT   review of documents detailing   the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants.

Documentation 145

Documentation Vaccines 145

STAT

SEPTEMBER 12, 2023

WASHINGTON — There’s a panel of 20 nutrition experts that has outsized influence on the American diet — and the food industry has worked hard to get friendly researchers into the group, new documents obtained by STAT show.

Documentation 145

Documentation 145

Fierce Pharma

SEPTEMBER 19, 2024

From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept.

Documentation 113

Documentation FDA 113

STAT

APRIL 13, 2025

In an unusual move, an audit of commercial health plans by Tennessee officials found that Express Scripts, one of the largest pharmacy benefit managers in the United States, violated state laws in its dealings with pharmacies, according to newly released documents.

Specialty Pharmacies 145

Specialty Pharmacies Insurance Documentation 145

STAT

SEPTEMBER 19, 2024

Specifically, a “large number of torn pieces” of documents that should have been kept to verify manufacturing and testing practices were found in the trucks, as well as in a scrap bag at a site run by Granules in Telangana, India.

Documentation 114

Documentation FDA Generic Medicine 114

STAT

MAY 1, 2024

In study documents, Mount Sinai doctors said the biopsies result in “the same amount of tissue loss” and “in effect, the same level of risk” for patients as standard DBS, because they are removing tissue that would otherwise be cauterized.

Documentation 145

Documentation FDA Nursing Homes 145

PhRMA

MARCH 29, 2023

This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatments that they need.

Insurance 320

Insurance Documentation 320

Fierce Healthcare

FEBRUARY 20, 2024

MA governor orders Steward Health Care to disclose withheld financial documents, says it must exit state 'as soon as possible' dmuoio Tue, 02/20/2024 - 16:37

Documentation 119

Documentation 119

STAT

JANUARY 7, 2025

The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide , according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.

Documentation 129

Documentation Insurance FDA 129

Fierce Healthcare

MARCH 8, 2024

WellSpan Health is taking the burden off its providers by deploying an AI-driven clinical documentation tool from Nuance. | DAX Copilot, from Microsoft’s speech recognition subsidiary Nuance Communications, integrates with Epic to draft clinical notes during visits.

Documentation 111

Documentation Communication 111

STAT

JULY 15, 2024

WASHINGTON – Top Food and Drug Administration officials met multiple times earlier this year to discuss the regulation of ultra-processed foods, according to internal agency calendars obtained by STAT.

Documentation 145

Documentation FDA 145

STAT

MARCH 7, 2025

  UnitedHealth acquired full or partial ownership stakes in more than 100 surgery centers in 2024, according to a STAT review of UnitedHealth’s newest annual financial documents.

Health Insurance Companies 144

Health Insurance Companies Insurance Documentation Hospitals 144

Fierce Healthcare

MAY 22, 2024

A wave of employee layoffs that UPMC announced last month was just one part of a broader restructure and operations “transformation” initiative, for which the nonprofit system has tapped management | An internal presentation obtained by Fierce Healthcare outlined April's “tough, but necessary" layoffs as one part of a broader look at the (..)

Documentation 138

Documentation 138

Drug Topics

JANUARY 16, 2023

In the 3 cases documented by researchers, hepatitis B surface antigen (HBsAG) levels were reduced by more than 50% after Japan began its COVID-19 vaccination program.

Vaccines 247

Vaccines Documentation 247

STAT

MAY 6, 2024

WASHINGTON – Two New York University professors collaborated directly with executives of the vaping company Juul without disclosing those relationships to academic journals or Congress, a STAT investigation reveals.

Documentation 145

Documentation 145

STAT

JANUARY 29, 2024

LONDON — There was something odd about these Alzheimer’s cases. Part of it was the patients’ presentations: Some didn’t have the classic symptoms of the condition. But it was also that the patients were in their 40s and 50s, even their 30s, far younger than people who normally develop the disease.

Documentation 145

Documentation 145

STAT

MAY 31, 2024

More than three years ago, the National Institutes of Health launched a $1 billion-plus initiative to find the root causes and potential treatments for long Covid , the chronic disease that has quickly changed the lives of millions of Americans.

Documentation 145

Documentation 145

STAT

OCTOBER 27, 2023

The Food and Drug Administration said on Friday that it has some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing the methods used by its makers to evaluate the risk of inadvertently making unwanted changes to patients’ DNA.

Documentation 141

Documentation FDA 141

Drug Topics

MARCH 24, 2024

At this year’s American Pharmacists Association Annual Meeting & Exposition, Mark Garofoli urged pharmacists to develop strong documentation practices and go beyond baseline federal regulations to care for patients with red flags.

Controlled Substances 216

Controlled Substances Documentation 216

STAT

DECEMBER 30, 2024

The authors found references to skin tone, pigmentation, or race  in 4% of the documents submitted before the FDA made its suggestion to diversify skin tone testing in 2013.

Documentation 139

Documentation FDA 139

IDStewardship

MARCH 17, 2024

Ctrl+F, but better Believe it or not, the reliable Ctrl+F command, cherished for bringing simplicity to document-searching, has been eclipsed by the advancements of AI. Ctrl+F can struggle with vague or common terms, making it challenging to find specific information in dense documents. No problem.

Documentation 338

Documentation Patient Care 338

PharmaVoice

APRIL 30, 2025

A leaked document revealed details about changes that could impact how the agency operates, but recent comments from FDA Commissioner Dr. Marty Makary have muddied the picture.

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FDA Documentation 147

Pharmacy Times

JUNE 24, 2022

The impact of the pandemic on the mental health of health care workers, including pharmacists and pharmacy staff, has been well documented.

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Documentation 182

STAT

MARCH 20, 2024

Johnson & Johnson has accused a long-standing employee of taking thousands of confidential files about commercial strategies as he left for a similar job at Pfizer, according to lawsuit filed in a federal court in New Jersey.

Documentation 134

Documentation 134

European Pharmaceutical Review

FEBRUARY 3, 2025

The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Inadequate validation of test methods : KVK-Tech failed to establish and document the accuracy, sensitivity, specificity and reproducibility of test methods.

FDA 88

FDA Documentation 88

Pharmacy Times

SEPTEMBER 13, 2024

In the absence of a common treatment for long COVID, researchers from around the world documented the best currently available therapies.

Documentation 153

Documentation 153

STAT

OCTOBER 14, 2022

In 2011, Walgreens executives were under pressure. Amid a growing addiction crisis, and with the country already awash in prescription painkillers, the federal government was demanding accountability from the pharmacy giant for filling thousands of opioid prescriptions written by doctors in suspiciously large quantities.  

Documentation 120

Documentation 120

Pharmacy Times

JULY 11, 2024

In a follow-up to the interim FTC report documenting the business practices of PBMs and the power they hold in the pharmaceutical industry, the Commission now seeks to sue the 3 largest PBMs in the country for driving up the price of insulin and other essential drugs.

Documentation 160

Documentation 160

Fierce Healthcare

AUGUST 14, 2024

Startup Abridge has notched it's largest partnership to date as Kaiser Permanente is making its generative AI tools for medical documentation available to more than 24,000 doctors across its system | Startup Abridge has notched it's largest partnership to date as Kaiser Permanente is making its generative AI tools for medical documentation (..)

Documentation 134

Documentation Hospitals 134

STAT

NOVEMBER 4, 2024

Such was the case for a neurodegenerative condition observed in a child and documented by Alfred Niemann in 1914. An eponym is a name derived from a person who first discovered a disease or who was otherwise closely associated with its identity.

Documentation 107

Documentation 107

BioPharm

MAY 3, 2024

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Documentation 111

Documentation FDA 111

Fierce Healthcare

JULY 22, 2024

Abridge has spent the last six years building generative AI tools to help doctors with medical documentation and is now putting that technology in the hands of hospital nurses. | Abridge has spent the last six years building generative AI tools to help doctors with medical documentation and is now putting that technology in the hands of hospital nurses. (..)

Mayo Clinic 126

Mayo Clinic Documentation Hospitals 126

Fierce Healthcare

OCTOBER 26, 2023

Abridge, a startup that developed artificial intelligence-based documentation solutions for healthcare, has seen rapid growth in the past year, propelled by a "tornado of tailwinds," according to c | Abridge, a startup that developed artificial intelligence-based documentation solutions for healthcare, has seen rapid growth in the past year, (..)

Mayo Clinic 138

Mayo Clinic Documentation 138