Risk Management for Drug Delivery Systems [Part 2]

Risk Management for Drug Delivery Systems [Part 2]

by | Feb 21, 2025 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Risk Management for Drug Delivery Systems [Part Two] Tips for executing combination product risk management In the previous part to this article, we...
Risk Management for Drug Delivery Systems [Part 2]

Risk Management for Drug Delivery Systems [Part 1]

by | Jan 21, 2025 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Risk Management for Drug Delivery Systems [Part One] What does a combination product risk management process look like? Let’s start with defining risk...
Application of User Fees New Guidance

Application of User Fees New Guidance

by | Jul 17, 2024 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Updates to the FDA’s guidance on application of user fees for combination products The FDA just updated its guidance on Application of User Fees...
FDA URRA New Draft Guidance

FDA URRA New Draft Guidance

by | Jul 10, 2024 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed The FDA has been extra busy this summer! Another key draft guidance has been published – this newest one on Use-Related Risk Analysis (URRA) for...
Essential Drug Delivery Outputs

Essential Drug Delivery Outputs

by | Jul 10, 2024 | Blog

Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Why essential drug delivery outputs?  The shift from requirements to outputs. Understanding Essential Drug Delivery Outputs: Why Outputs and not...