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 127

Documentation FDA 127

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 139

Documentation Hospitals 139

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

Fierce Pharma

JUNE 7, 2023

On Wednesday, that vision came into better focus as the FDA released a document showing how the agency views the drug. . | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval.

Documentation 127

Documentation FDA 127

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

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

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 318

Insurance Documentation 318

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 130

Documentation Insurance FDA 130

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

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

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

Fierce Healthcare

OCTOBER 16, 2024

Microsoft recently unveiled several new artificial intelligence capabilities for healthcare organizations designed to help analyze diverse medical data, streamline nursing documentation and enable | Microsoft recently unveiled several new AI capabilities for healthcare organizations designed to help analyze diverse medical data, streamline nursing (..)

Documentation 137

Documentation 137

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

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

Hospital Pharmacy Europe

JULY 1, 2025

In response to this, the Leeds Teaching Hospitals NHS Trust (LTHT) pharmacy team has recently launched its ‘Digital Induction’ document. Initial feedback has been overwhelmingly positive, leading to the creation of additional documents tailored for line managers and pharmacy students with specific digital needs.

Hospitals 84

Hospitals Documentation Communication 84

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

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

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

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.

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Documentation Patient Care 338

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

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 142

Documentation FDA 142

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

Drug Topics

JUNE 11, 2025

This led researchers to explore a specific region of the world in order to better document patients’ understanding of the disease. The prevalence of psoriasis in the Gulf countries is not well-documented; however, recent studies suggested that psoriasis affects 0.5%-5.3%

Immunization 315

Immunization Documentation Specialty Pharmacies Compounding 315

Drug Topics

JUNE 11, 2025

The study cohort included 670 patients who were diagnosed with PsA of at least a 3 month duration and have active plaque psoriatic skin lesions or a documented medical history of plaque psoriasis. READ MORE: Significant Knowledge Gap Exists in Patient Awareness of Psoriatic Disease The study found that 54.2%

Specialty Pharmacies 315

Specialty Pharmacies Compounding Independent Pharmacies Immunization 315

STAT

JUNE 9, 2025

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds.    Sign up here. And another week begins — I kind of cannot believe that we’re already nearing “mid” June.

Documentation 100

Documentation 100

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

The FDA Law Blog

JANUARY 9, 2025

Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).

FDA 105

FDA Documentation Labelling 105

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.

Documentation 182

Documentation 182

STAT

JUNE 27, 2025

And so Hassan called on GSK to return the product to market and, meanwhile, asked for numerous documents concerning pricing, rebates and communications with regulators. This marks the second time in recent months that GSK has angered a lawmaker over the asthma inhaler switch.

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Documentation Communication Hospitals 99

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 135

Documentation 135

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

JUNE 10, 2025

Low uptake of vaccination to protect against invasive pneumococcal disease (IPD) was observed both before and after a pneumococcal-related hospitalization, with countless missed vaccination opportunities documented.

Hospitals 65

Hospitals Vaccines Documentation 65

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