Newsletter | July 22, 2024

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

SPONSOR

Ophthalmic drug delivery has gained significant attention because of its potential to deliver drugs directly to the eye without systemic exposure. However, the eye presents unique challenges because of its complex anatomical structure and the presence of various protective barriers. Consider the challenges to effective delivery of drugs to the eye, delve into the intricacies of ophthalmic drug delivery, and consider the advantages of nanoparticles as an enabling technology for ocular drug-delivery systems (DDS).

FEATURED EDITORIAL

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

By Charles L. Mauro, CHFP and Christopher Morley, MSc., Mauro Usability Science

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.

INDUSTRY INSIGHTS

Nasal Vaccine Development, Manufacturing, And Device Selection

White Paper | By Mark Ignaczak, Catalent

When developing a nasal delivery program, a partner with experience in development and manufacturing who can see a program through small-scale clinical to commercial supply is crucial.

How DFM Promotes Scalability, Repeatability, And Profitability

Article | SMC Ltd.

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.

Identify And Mitigate Absorption Risks With PBPK Modeling

Webinar | Lonza

See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

Dosage Form Optimization For Patient-Centric Drug Development Process

e-book | Catalent

In designing products with patients in mind by utilizing superior formulation and drug delivery technologies in the early phases of development, companies can minimize risks on the path to market.

Overcoming Melt Processing Challenges For Polymer-Based Delivery Systems

Article | DSM Biomedical

Discover how a polymer platform which can be easily applied with hot melt processing enables processing at a relatively low temperature, preserving the potency of temperature sensitive APIs.

SOLUTIONS

Highly Flexible And Customizable On-Body Delivery System Platform

Stevanato Group

Committed To Quality, Collaboration, Service, And Innovation

West Pharmaceutical Services, Inc.

Excel IV: An Evolving Market Affirms The Value Of An Established Offering

B. Braun OEM Division