Newsletter | August 19, 2024

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

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The premier event on pre-filled syringes and injection devices brings together key field players to discuss the breakthroughs that are propelling the industry forward. A comprehensive agenda covers critical topics, including sustainability, large-volume injections, digital health, and regulatory compliance. Additionally, the exhibit hall featuring 120+ exhibitors, poster presentations, lightning sessions, lively Q&As, networking activities, and Drug Delivery Innovation Awards makes this event a must-attend. Register now

FEATURED EDITORIAL

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), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.

INDUSTRY INSIGHTS

Enhancing The Solubility Of High Lipophilicity Drugs Via Spray Drying

A new R&D project shows the solubility and dissolution characteristics of Itraconazole can be improved by helping them maintain an amorphous state after spray drying with selected hydrophilic polymers.

Examining The Emergence Of Unit- And Bi-Dose Nasal Sprays

Nasal spray administration of medicine offers advantages over oral and IV delivery. Experts discuss the advantages and opportunities of adopting unit- and bi-dose nasal delivery technology.

Formulation Development For Injectables

A uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.

How An Innovative Process Is Disrupting Spray Drying

Review a commercially-ready process capable of reproducing spray-dried dispersions with less manufacturing complexity and environmental impact, and out-designing and outperforming spray drying.

Unlocking A Patient Preference For Rapid Onset In Treating Migraines

Examine the case study and learn how formulating an orally disintegrating tablet (ODT) created a convenient dosage form with a shorter Tmax for the treatment of acute migraine.

New Polymer Overcomes Limits In Sustained Drug Delivery In Ophthalmology

The eye's physiology complicates the development of new therapies and necessitates innovative drug delivery methods. Biodegradable polymers show promise in addressing these challenges.

SOLUTIONS

Small Molecule Capacity Update: Leveraging Nanoparticle Technology

Highly Flexible And Customizable On-Body Delivery System Platform

IV Solution Expansion