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Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection

Fierce Pharma

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.

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Which Clinical Documentation AI Tools Are Health Systems Using?

MedCity News

Health systems across the country are launching enterprise-wide deployments of AI-powered clinical documentation tools. The post Which Clinical Documentation AI Tools Are Health Systems Using? appeared first on MedCity News.

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How A Physician Group Is Using AI to Save Clinicians 3+ Hours Per Day on Documentation

MedCity News

Alpine Physician Partners — which operates primary care organizations in several states — is implementing Ambience Healthcare’s documentation and coding tool after a successful pilot. The post How A Physician Group Is Using AI to Save Clinicians 3+ Hours Per Day on Documentation appeared first on MedCity News. hours per day.

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FDA document outlines apparent agency support for full approval of Biogen, Eisai's Leqembi

Fierce Pharma

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.

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Elation Health Launches Its Own Clinical Documentation Tool

MedCity News

The post Elation Health Launches Its Own Clinical Documentation Tool appeared first on MedCity News. Primary care EHR company Elation Health recently launched an AI-powered ambient note generation tool called Note Assist. The tool is now competing with those made by Microsoft, Abridge, DeepScribe and Suki.

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Most Physicians Are Excited About Clinical Documentation AI, Report Shows

MedCity News

Providers are hungry for more tools designed to simplify these tasks, namely documentation, a new report shows. The post Most Physicians Are Excited About Clinical Documentation AI, Report Shows appeared first on MedCity News.

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Uncovering the Hidden Insights in Clinical Trial Documents: Critical Steps to Intelligent Document Processing

MedCity News

A typical clinical trial generates over 13,000 documents in various formats (text, voice, video, apps, and web entries), making data gathering, organization and analysis challenging. It can analyze diverse documents (written, video, voice, etc.), Digital twin data lakes enable insights from past trials and create audit trails.

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