Newsletter | January 25, 2024

01.25.24 -- The 10 Guiding Principles Of GMLP Identified By The FDA, HC, And MHRA


The 10 Guiding Principles Of GMLP Identified By The FDA, HC, And MHRA

The U.S. FDA, Health Canada (HC), and the U.K.’s Medicines and Healthcare Regulatory Agency (MHRA) have come together and identified 10 guiding principles, with the aim of developing good machine learning practices (GMLP) that will address the unique nature of AI/ML-driven medical devices.


The Algorithm Is In: 5 Ways AI Is Transforming Medicine

AI is transforming the medical field, offering innovative solutions to complex problems. Explore the potential of AI in revolutionizing healthcare and leveraging data to improve patient experiences.

Key Considerations For Selecting Flexible Fillers

Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

Navigating A Manufacturing Transfer During Global Disruptions

Manufacturing transfer difficulties as a result of inadequate communication or supply chain disruption can be minimized or eliminated through transparency and collaboration.

Partnership Goals For Scale-Up Success

As demand for capabilities and resources grows throughout a project, both become strained in-house, and the scale-up process becomes a steeper hill to climb.


How To Operate In The AI Compliance Vacuum

Key Regulatory-Fueled Updates On Combination Products As We Enter 2024

Key Considerations In "Intended Use" And "Indications For Use" Statements For Medical Devices

The Secret To Medical Device Development Success: A Mindset For Continuous Learning

Can Aptamers In Wearable Sensors Mean A Revolution In Healthcare?


Pharma + Tubing Retainers

Comparing “Apples To Apples” With Medical Device Injection Molding RFQs

Capacitors For Medical Implantable Devices

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