The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. FDA interprets the term “pattern” to mean “multiple, sequential, or repeated measurements of a signal or from a signal acquisition system.”

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FDA Labelling Documentation Communication 52

Pharmacy Times

JULY 2, 2025

In an interview with Pharmacy Times , LeAnne Kennedy, PharmD, BCOP, CPP, FHOPA, oncology clinical manager at Atrium Health Wake Forest Baptist in Winston-Salem, North Carolina, shares insights about the facility’s Wake Outpatient Transplant Program and highlights its positive impact on patient care outcomes.

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Compounding Pharmacies Hospitals Immunization Compounding 65

Pharmacy Times

JULY 3, 2025

In an interview with Pharmacy Times , LeAnne Kennedy, PharmD, BCOP, CPP, FHOPA, oncology clinical manager at Atrium Health Wake Forest Baptist in Winston-Salem, North Carolina, highlights the extensive role of pharmacists in the Wake Outpatient Transplant program. Well, this is an outpatient unit.

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Specialty Pharmacies Compounding Pharmacies Hospitals Immunization 65

ISPE

OCTOBER 27, 2022

The COVID-19 pandemic underscores the importance of DHTs through the increased reliance on telemedicine services and remote patient monitoring programs to ensure patient safety and triage scarce hospital resources.

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Health and Personal Care Stores FDA Communication Clinic Management 52

pharmaphorum

AUGUST 26, 2021

UK-based Optellum has developed an AI-powered clinical decision support – called Virtual Nodule Clinic – that it says acts as a “digital biomarker”, looking for signs of cancer in computed tomography (CT) scans. It was approved by the FDA in March, and is starting to roll out in US hospitals.

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Hospitals Clinic Management FDA 72

ISPE

OCTOBER 27, 2022

The COVID-19 pandemic underscores the importance of DHTs through the increased reliance on telemedicine services and remote patient monitoring programs to ensure patient safety and triage scarce hospital resources.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52