Newsletter | December 17, 2024

12.17.24 -- A Closer Look At FDA's Controversial Rule On Laboratory Developed Tests

FEATURED EDITORIAL

A Closer Look At FDA's Controversial Rule On Laboratory Developed Tests

Issued earlier in 2024, FDA’s final rule on laboratory developed tests (LDTs) ended the agency’s long-standing policy of exercising enforcement discretion with regard to medical device regulations that would otherwise apply to labs that prepare and/or market LDTs. 

INDUSTRY INSIGHTS

How Recent Trends Impact Bringing Your Molecule To Market

With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

5 Ways Manufacturers Optimize Consumables Programs With RFID

RFID technology helps manufacturers who rely on repeat sales of consumable components combat threats to profitability and performance, while ensuring superior operability for their end-use customers.

3 Important Considerations When Evaluating A Silicone Manufacturing Partner

Choosing the right CMO for your silicone medical device project is crucial. Learn the three key factors that can ensure your project's success.

Overcoming Melt Processing Challenges

Discover how a biodegradable polymer platform, easily applied with hot melt processing, enables processing at a relatively low temperature while preserving the potency of temperature-sensitive APIs.

Capacitors For External Defibrillators

Explore the components of a defibrillator circuit and learn why capacitors are vital, directly influencing the pulse size, shape, and overall efficiency of the device.

Custom Tubing: Exceeding Expectations

Experience superior quality and unmatched expertise with custom tubing solutions that ensure optimal performance.

ARTICLES YOU MAY HAVE MISSED

How The EU AI Act Impacts Medical Device Manufacturers

Medtech: Capitalize On These 4 Trends To Thrive In 2025

Increasing Diversity In Medtech Innovation: A Personal And Professional Perspective

We're Heading Toward A Bottleneck For EU MDR Approvals; How To Get Ahead

How Does Robotics Aid Occlusion Testing For Drug Delivery Devices?

BULLETIN BOARD

Development Kit Time Metered Dosing Video

Explore a time-metered dosing system that integrates disc pumps, pneumatic valves, and strobe visualization, offering precise liquid handling for diagnostics, reagent dispensing, and inkjet printing.

RESOURCES

An Innovative Platform For The Delivery Of RNA Therapeutics

Pharma+ Tubing Retainers

Transforming Drug Delivery

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