Best of 2024: Top 10 Insights In Drug Formulation & Delivery

#1 - Understanding Essential Drug Delivery Outputs: Things To Know About EDDOs

Fran DeGrazio summarizes and comments on key clarifications and recommendations that emerged in a Drug Delivery Live! online event on the FDA's draft guidance on Essential Drug Delivery Outputs (EDDOs), which she moderated.

#2 - New FDA QMSR: Its Role In Part 4 Compliance For Combination Products

Drug Delivery Leader Executive Editor Fran DeGrazio welcomed quality and risk management experts Laurie Auerbach and Edwin Bills in a discussion of the history and intentions of the new QMSR and what it means for combination product manufacturers.

#3 - A Critical Analysis Of FDA Human Factors IFU Guidance For Drug Delivery Devices

Drug administration by lay users is becoming more common. Is current FDA guidance viable for demonstrating safe and effective use for critical devices and systems? No.

#4 - Combination Products: Market Trends And Regulatory Considerations

Combination products provide significant avenues for increasing patient adherence and overall efficacy. This e-book outlines the opportunity and identifies strategies for gaining regulatory approval.

#5 - New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis

On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR). Take a closer look at the role of ISO 13485, expectations for compliance with ISO 14971, and more.

#6 - Needle-Free Rescue Therapies With Crossject's Patrick Alexandre And Dan Chiche

Crossject's CEO and Chief Medical Officer discuss common rescue scenarios, rapid self-administration of treatments, and collaborative development efforts across drug formulation and device engineering.

#7 - Auto-injectors: Global Trends & Market Forecast

Auto-injectors offer a dependable method for delivering medication, especially during emergency scenarios. This article shares new market research, including macro trends, smart features, disposable vs. reusable trends, and more.

#8 - Selecting Drug Delivery Systems For Higher Doses, Higher Viscosities, And Lower Risk

As high-volume, high-viscosity formulations come to market, pharmaceutical and biotech companies must make critical device choices from an array of largely unproven options. Explore how companies can de-risk their device selection.

#9 - Use-Related Risk Analysis For Combination Products

One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process.

#10 - Taking Combination Products To The Next Level: Combining Gene Therapies, Carrier Systems, And Medical Devices

Drug delivery is one of the most significant obstacles to advancing gene therapies. Examine the opportunities for success in combining novel medical devices to improve delivery of gene therapies.