Newsletter | January 13, 2025

01.13.25 -- Developing Regulatory Strategies For Combination Products

FEATURED EDITORIAL

Developing Regulatory Strategies For Combination Products

In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor Susan Neadle. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.

Essential Drug Delivery Outputs: Things To Know About EDDOs

The FDA draft guidance on Essential Drug Delivery Outputs (EDDOs) stirred interest from industry in how best to respond. In this article, Fran DeGrazio summarizes and comments on key clarifications and recommendations that emerged in a Drug Delivery Live! online event on the topic, which she moderated.

INDUSTRY INSIGHTS

PFAS In Medical Devices: Expert Insights On Frequently Asked Questions

Learn about Per- and Polyfluoroalkyl Substances in medical devices, covering environmental concerns, health risks, testing, alternatives, and management strategies with Shalene Thomas of Battelle.

Wearable Injectors: An Alternative To Traditional Intravenous Administration

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

Nest Designs To Streamline Fill/Finish Of Ready-To-Use Cartridges

Here, we examine how an optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics, improving efficiency in pharmaceutical production.

Nanotechnology Across Multiple Delivery Routes For Small, Large Molecules

Explore the latest in nanotechnology advancements including recent clinical data, formulation applications, and API optimization to NanoImprove formulations.

Pediatric Patient Considerations During Dose Development

Specific dosing guidelines and acceptable dosage forms for pediatric patients need to be developed to optimize therapeutic efficacy and limit and prevent serious adverse side effects.

The Growth Of Sterile Injectables

Better understand why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.

Less Mess, Less Stress, Best Expressed: An Alternative To Spray Drying

Although well-established processes, spray drying and hot-melt extrusion can be outperformed in bioavailability, cost-savings, manufacturing speed, environmental impact, and more.

SOLUTIONS

Polyester Amide Platform For Long-Acting Drug Delivery

Real World Dosing Solutions For Patients

AdvaTab Technology Orally Disintegrating Tablets

Robotic Aseptic Filling Services