FDA Human Factors Resources

Wendy News

FDA Draft Guidance on Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA:


This draft guidance provides FDA’s current thinking on general HF considerations and tools for developing a generic combination product under ANDA submissions. https://www.fda.gov/media/102349/download

FDA Guidance on Safety Considerations for Product Design to Minimize Medication Errors:


Looking for best practices from the FDA to improve your drug product and container closure design? See this guidance at https://www.fda.gov/media/84903/download

FDA Draft Guidance on Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors:


This guidance focuses on safety considerations for your product’s container label and carton labeling design. https://www.fda.gov/media/85879/download

FDA Perspectives on Human Factors in Device Development:


A great presentation of HF principles for device development can be found at https://www.fda.gov/media/84709/download

The Role of Human Factors Engineering in Combination Product Post Approval Changes (presented at PQRI Conference in 2019):


Expanding your combination product indications post launch? Visit https://pqri.org/wp-content/uploads/2019/04/1-PQRI-April-2019_CDER-HF-Presentation_QNguyen.pdf for information about how HFE can be applied.


If you want to learn about Kymanox's Human Factors Regulatory and Strategy program, contact us today!

huras
We collect, use, and process your data according to our Privacy Policy. By submitting this form, you also agree to subscribe to receive emails with thought leadership, news, and tips from Kymanox. *

Get More Done.

Contact Kymanox today by calling 919.246.4896 or sending email to sales@kymanox.com.