by Thomas Agrait | Sep 27, 2018 | Collaboration, Commitment, Communication, Community Service, FDA, FDA New Guidelines, FDA News, Improvement, Public Health, Public Safety, Readers Engagement, Social Responsibility
Caution When Using Pen Needles to Inject Medicines: Today, the U.S. Food and Drug Administration issued a Safety Communication on “Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication.” The FDA is reminding patients, caregivers, and healthcare...
by Thomas Agrait | Sep 24, 2018 | Communication, Compliance, FDA New Guidelines, Guidelines, Improvement, Innovation, Process Improvement, Professional Development, Regulatory, Social Responsibility
The FDA Issues Final Guidance – Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics Today, the U.S. Food and Drug Administration (FDA) released the final...
by Thomas Agrait | Sep 6, 2018 | Audits, Biotech, Communication, Compliance, FDA New Guidelines, Process Improvement, Quality Systems, Regulatory, Technology
Quality in 510(k) “Quik” Review Program Pilot Today the U.S. Food and Drug Administration (FDA) is launching the Quality in 510(k) (“Quik”) Review Program pilot. The goal of this pilot is to simplify how manufacturers of certain moderate-risk medical...
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