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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. While the final guidance includes the same definition of “signal” as that used in the draft guidance—i.e.,

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FDA Labelling Documentation Communication 52

Hospital Pharmacy Europe

SEPTEMBER 24, 2024

A further study presented during the ESC Congress was the EARTH-STEMI meta-analysis that, as highlighted by Professor Gianluca Campo, confirms the clinical benefits of complete revascularisation in older patients with ST segment elevation myocardial infarction, at least in the first four years.

Documentation 52

Documentation Hospitals Clinic Management Patient Care 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 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