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Investigation launched into alleged animal welfare violations at Neuralink

pharmaphorum

Reuters said it has interviewed 20 current and former Neuralink employees in its investigation, as well as reviewing internal company documents. We only know Animal 20’s story because we sued @UCDavis for the medical records & are still engaged in a lawsuit to get access to photos and videos of these experiments.

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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

The FDA Law Blog

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements. We should explain what RIEs are.

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Connecting with Patients at Home

Pharmacy Is Right For Me

In addition to learning more about unique pathways on-site, you can also understand more about the career paths of these pharmacists here on our blog. Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC).

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

The FDA Law Blog

This guidance, when finalized, will replace the original version of this document finalized in 2017. There is ample data collected on them during this 24/7 monitoring period such as case notes, contemporaneous patient medical records, and patient tapes. Patients that use ESD undergo continuous 24/7 monitoring.

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Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

The FDA Law Blog

The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. objective clinical outcomes in the context of detailed medical record collection).

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Health Data Management: Everything You Need to Know

Viseven

Here are some of the key challenges the industry faces: Fragmented data Health data can live in various databases and spreadsheets and come in different formats, such as text documents, video, and audio files. It outlines how medical data should be used, protected, and disclosed. Trust the numbers and hands-on expertise.

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Sentinel Events Should Result In A Blameless Society — Not Make The Employee The Scapegoat

The Happy PharmD

These documents focused on why the sentinel event occurred. In this particular case, the physician folded the medication order when he placed it in the nurse’s bin. The nurse transcribed the medication order on the patient’s (nurse’s) record system. Blaming Employees For Sentinel Events.