by Jonathan Amaya-Hodges | Jul 14, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed EU COMBINE Pilot Expands to Cover Investigational Devices and ATMP Combination Studies Quick take: Phase 2 of the European Commission’s COMBINE...
by Jonathan Amaya-Hodges | Jan 17, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Rescuing a Time-Critical IND Amendment for a Clinical-Stage Injectable Program Clinical-Stage Biopharma | Injectable Therapy in Prefilled Syringe ...
by Jonathan Amaya-Hodges | Jan 9, 2026 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Developing an internal business case for a Combination Product When Pharma and Biotech leaders begin considering a delivery device for their...
by Jonathan Amaya-Hodges | Dec 9, 2025 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed FDA’s new draft guidance is providing clarity on cross-center master files FDA recently issued a new draft guidance titled Cross-Center Master...
by Jonathan Amaya-Hodges | Dec 3, 2025 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed EUDAMED will become mandatory for selected modules… Pharma/Biotech sponsors of co-packaged devices and other separately distributed devices...
