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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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Abridge clinches $150M to build out generative AI for medical documentation

Fierce Healthcare

. | Along with the funding round, Abridge also announced an enterprise agreement with Connecticut-based Yale New Haven Health System to give thousands of clinicians access to its AI-powered clinical documentation technology.

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STAT+: FDA cites Granules, a large Indian generic drug manufacturer, for tossing truckloads of key documents

STAT

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.

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STAT+: HCA to expand the use of AI tool to automate clinical documentation in ER

STAT

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.

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STAT+: Juul spent big to court Black leaders to promote its e-cigarettes, new documents show

STAT

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…

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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

The FDA Law Blog

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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Complying with REMS Training and Documentation Requirements

Pharmacy Times

Michael Singel, PharmD, discusses the logistics of complying with the Risk Evaluation and Mitigation Strategy program for bispecific antibodies at his institution and addresses training and documentation requirements.