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Investigation launched into alleged animal welfare violations at Neuralink

pharmaphorum

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. Without proper context, information from medical records and study data can be misleading.”. — Physicians Committee (@PCRM) November 30, 2022.

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

FDA Law Blog: Biosimilars

There is ample data collected on them during this 24/7 monitoring period such as case notes, contemporaneous patient medical records, and patient tapes. Every use of ESD is recorded, as is every behavior that falls within the intended use. Patients that use ESD undergo continuous 24/7 monitoring.

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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).

Hospitals 130
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When Should a 510(k) Include Clinical Data?

FDA Law Blog: Biosimilars

electronic health records, claims). These include: results of pre- and post-market clinical investigation(s) of the device (i.e.,

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Episode 749: Three reasons why 1 clinical pharmacist on the unit = 2 in the office

Pharmacy Joe

If I’m trying to determine whether venous thromboembolism prophylaxis is appropriate, it is much faster and accurate to see the sequential compression stockings (SCDs) on the patient’s legs than it is to search the medical record for documentation that SCDs were applied.

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Episode 749: Three reasons why 1 clinical pharmacist on the unit = 2 in the office

Pharmacy Joe

If I’m trying to determine whether venous thromboembolism prophylaxis is appropriate, it is much faster and accurate to see the sequential compression stockings (SCDs) on the patient’s legs than it is to search the medical record for documentation that SCDs were applied.

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

FDA Law Blog: Biosimilars

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.