February at IAA

February was a month best described by the word “variety.”

We worked on several projects across a wide range of FDA submission types for both the Center for Drug Evaluation and Research (CDRE) and the Center for Devices and Radiological Health (CDRH).

These projects included:

• Three combination drug product NDA submissions
  • Two reconstitution kits for injection
  • One catheter delivered product
• A combination drug product 505(b)(2) submission for an autoinjector
• A combination drug product 351k submission for a pen injector
• Two combination drug product ANDA submissions
  • Autoinjector
  • Variable dose pen injector
• A smart device accessory 510(k) submission for a pen injector

Note that each submission type represents unique requirements and challenges that we must navigate.

No matter what your submission type, Interface Analysis Associates can help manage your human factors program and help with your regulatory and market success.

Contact us to learn more.

Anthony D. Andre, Ph.D., CPE is a leading expert in Human Factors, Usability, and Ergonomics. A past President, Titan and Fellow of the Human Factors and Ergonomics Society (HFES) and a Fellow of the International Ergonomics Associates (IEA), Dr. Andre has held numerous leadership roles in the field.  

In 1993, Dr. Andre founded Interface Analysis Associates (IAA), a consulting firm specializing in designing and evaluating user experiences and interfaces for a wide range of products and industries with a current focus on drug delivery systems and medical devices. IAA has earned numerous prestigious awards, including the User-Centered Design Award. 

Dr. Andre is also a co-founder and Adjunct Professor in the Human Factors and Ergonomics Graduate Program at San Jose State University, where he has taught since 1993. Previously, he was a Principal Scientist at NASA, developing next-generation cockpit and air traffic control interfaces.   

He is the Founder and Editor-in-Chief of the journal Human Factors in Healthcare and the Founder and Vice-Chair of the International Symposium on Human Factors and Ergonomics in Healthcare.