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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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

FDA 52

FDA Labelling Documentation Communication 52

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

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical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

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In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical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

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52