European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 84

Manufacturing Pharma Food and Drug Administration Safety 84

Nixon Gwilt Law

SEPTEMBER 7, 2023

Pediatric healthcare innovation companies—especially those in AR/VR/XR, Digital Therapeutics (“DTx”), Remote Monitoring, Virtual Care Management, Telehealth, and Telebehavioral health—need a deep understanding of the laws and regulations that govern this special market.

Food and Drug Administration 52

Food and Drug Administration Education Insurance Healthcare 52

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. However, some specific trends demand a closer look.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98

Medico Reach

OCTOBER 17, 2022

Since the inception of the clinical specialization, the orthopedic industry has relied on reusable surgical instrumentation. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. However, some specific trends demand a closer look.

Medical 52

Medical Food and Drug Administration Healthcare Healthcare 52