Newsletter | August 5, 2024

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

FEATURED EDITORIAL

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. They highlighted specific areas of risk that your organization may need to address. Drug Delivery Leader Chief Editor and Community Director Tom von Gunden was on hand to provide an overarching framing of the topics within the context of the new QMSR.

INDUSTRY INSIGHTS

Unlocking The Potential Of Self-Administered Injectable Medicines

Explore how patients and providers perceive and consider using patient-administered medicines to manage chronic conditions, specifically self-administered injectables and on-body delivery systems.

The Impact Of PFAS Regulations On Drug Delivery Devices

By adopting a strategic approach and embracing necessary measures, the medical device industry can transform regulatory challenges surrounding PFAS into opportunities for innovation and growth.

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.

Utilizing Nanoparticle Technologies For A More Sustainable Value Chain

The pharma industry is identifying ways to make processes more sustainable. Learn how nanoparticle engineering technology can both empower sustainability goals and lead to better patient outcomes.

Intranasal Drug Product Development — From Formulation To Scale-Up

Explore the key advantages of intranasal drug delivery, including its potential to rapidly treat conditions like migraines and headaches, and deliver medications directly to the brain.

Dry Powder Inhalable Vaccines For Shelf Stability And Global Access

What if a formulation that removed the need for cold chain distribution was possible? Explore formulation and manufacturing considerations for vaccines with dry powder respiratory delivery.

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

Spray drying and hot-melt extrusion are well-established processes, but each can be outperformed in terms of bioavailability, cost-savings, manufacturing speed, environmental impact, and more.

SOLUTIONS

Autoinjector For Deep Intramuscular Delivery

A Technology-Driven CDMO Delivering End-To-End Drug Delivery Services

European Center Of Excellence For Clinical Biologics