USFDA issues draft guidance on bridging data for combination products

US FDA issued a draft guidance in regards to how drug-device and biologic-device combination product sponsors can bridge data from earlier stages or development or other development programs to support an application.

The 14-page guidance gives a detailed explanation on how sponsors are able to derive an analytical framework for the identification of information gaps that could be addressed with bridging. It also provided 3 concrete examples for references.

This guidance is scheduled for finalization by the end of 2022.

More details on USFDA website: https://www.fda.gov/media/99140/download

European Commission released an aide memoire on practicing good distribution practice (GDP)

The European Commission released an aide memoire to assist pharmaceutical wholesalers in practicing good distribution practice (GDP).

The 6 page document ranges from a form of general questions to specific questions relating to quality systems, verification of a medicine’s safety features, suspected falsified medicinal products and decommissioning of unique identifiers (UIs).

The aide memoire can be download from the EC website:
https://ec.europa.eu/health/sites/health/files/files/falsified_medicines/inspection_gdp_aidememoire_en.pdf