Fierce Healthcare

APRIL 24, 2024

Medical devices and other innovations that make acute and on-going at-home clinical management possible are receiving a boost in attention from FDA. The Food & Drug Administration’s device center launched an initiative to promote at-home medical device development with a focus on health equity in at-home care.

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FDA Clinic Management 112

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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

IDStewardship

JUNE 19, 2025

Despite advancements in treatment, certain patients may exhibit delayed responses, have drug-resistant TB, be at risk for drug-drug interactions, or have comorbid conditions that considerably complicate clinical management. In 2014, the US FDA approved this regimen, and it features in the latest WHO guidelines for LTBI treatment.

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HIV Treatment and Prevention Agents Adverse Reactions Dosage Labelling 130

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.

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ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Table 3: Example classification of DHTs. .

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Table 3: Example classification of DHTs. .

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52