Newsletter | September 16, 2024

09.16.24 -- FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

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The FDA Guidance on EDDO: What to Know, What to Do

Join Drug Delivery Leader Executive Editor, Fran DeGrazio, as she engages combination product regulatory experts in a candid conversation about the FDA’s recent draft guidance on Essential Drug Delivery Outputs (EDDO). This dynamic discussion will cover aspects such as design verification, control strategies, human factors, and post-approval changes. Registration is free for this digital event.

FEATURED EDITORIAL

FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)

The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

INDUSTRY INSIGHTS

The Path To Self-Administration: Moving From PFS To Auto-Injector

Review advice to pharma companies on three key areas of auto-injector device development: patient-centered design, container and device considerations, and manufacturing partner selection.

Patient Centric And Commercially Viable Pediatric Product Development

Srinivasan Shanmugam, Ph.D. discusses pediatric patient compliance, regulations impacting pediatric trial access, excipients within pediatric formulations, and more.

How DFM Promotes Scalability, Repeatability, And Profitability

DFM discussion must be concise and backed by both historical data and up-to-the-minute insights, e.g., discovered through prototyping, test runs, etc.

Nanotechnology To Improve The Performance Of Your Medicines

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

Optimizing Nest Design To Streamline Fill Finish Of Ready-To-Use Cartridges

An optimized nest design for pre-fillable cartridges was designed using numerical simulation and data analytics, improving efficiency in pharmaceutical production.

SOLUTIONS

Enabling The Delivery Of Complex Biologics With Ergonomic Solutions

Real World Dosing Solutions For Patients

IV Solution Expansion