Cross-Center Master Files

Cross-Center Master Files

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Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed FDA’s new draft guidance is providing clarity on cross-center master files FDA recently issued a new draft guidance titled Cross-Center Master...
EUDAMED is mandatory

EUDAMED is mandatory

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...