Newsletter | September 12, 2024

09.12.24 -- How Early Talks With The FDA Can Pave Your DTx Approval Pathway

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Medbio offers the broadest spectrum of medical molding solutions – from components to complete assemblies. Offering precision custom molding capabilities, full-service medical manufacturing, custom-built automation cells and value-added assembly plus standard protective parts, medical packaging and labware components, Medbio is the one partner you need. We have worked with 1,500+ medical customers, have 80,000+ square feet of cleanroom manufacturing and the technical experts to solve your challenges.

FEATURED EDITORIAL

How Early Talks With The FDA Can Pave Your DTx Approval Pathway

Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.

INDUSTRY INSIGHTS

The Impact Of 3D Printing On Micro Molding — A Synergistic Approach

Explore the future of micro manufacturing, where the convergence of micro molding and 3D printing promises to redefine what's possible in the creation of intricate, high-quality components.

Elements Of Design: Dealing With Suspect Parts

Learn about a solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to automatically reject parts that do not make the cut in the molding process.

Sustained, Controlled Drug Delivery To The Eye

Examine how a platform that leverages polymeric implantable drug delivery systems enables improved bioavailability, patient compliance, and mitigation of issues associated with repeated injections.

ARTICLES YOU MAY HAVE MISSED

Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD

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

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FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

RESOURCES

Characterization & Delivery Of Ultra-Viscous & Non-Newtonian Formulations

Cut Through Complexity, Gain Speed, And Get Your Drug To Patients ASAP

Aqueous Cleaning Processes

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