Newsletter | September 5, 2024

09.05.24 -- FDA Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection

FEATURED EDITORIAL

FDA Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection

The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

INDUSTRY INSIGHTS

Applying Automation To The Manufacture Of Drug Delivery Devices

Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.

Proven Versatile, Easy, And Sustainable Medical Device Materials

There is a need for environmentally sustainable materials in the medical device industry, and Celanese’s Hostaform® MT® POM ECO-B fills the gap. From feasibility to development to commercialization, Celanese’s scientists and engineers are there to provide development services, GMP material supply, and regulatory support.

Selecting Capacitors For Life-Critical Applications

This white paper explores regulation, testing procedures, and supplier considerations to assist in choosing the best components for each medical application. 

Streamlining Catheter-Based Devices With Advanced Multilayer Tubing

Discover how breakthroughs in multilayer tubing extrusion technology enable next-generation catheter-based medical devices.

Why Engineers Water Down Part Design

Discover why designing for manufacturability shouldn't mean settling for less, but rather striving for innovation with every micron.

ARTICLES YOU MAY HAVE MISSED

The Learned Intermediary Doctrine Sees Curious Change In California

Is Your Lab Ready For A LIMS Implementation?

FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

Answer These Questions To Guide Your Prototyping Strategy

Understanding The Potential Of AI Med Devices Amid Regulatory Challenges

BULLETIN BOARD

The Piezoelectric Disc Pump Development Kit

Jumpstart your next project with the piezoelectric disc pump evaluation kit and start exploring the unique feature set of our ultrasonic micropumps.

RESOURCES

Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

Assembly Services

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