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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. While the final guidance includes the same definition of “signal” as that used in the draft guidance—i.e., Karst & Steven J.

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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.

Compounding Pharmacies 65

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.

Specialty Pharmacies 65

Specialty Pharmacies Compounding Pharmacies Hospitals Immunization 65

ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Description. Artificial intelligence (AI)/machine. learning (ML).

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Description. Artificial intelligence (AI)/machine. learning (ML).

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52