FDA Law Blog: Biosimilars

MAY 8, 2023

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs).

Documentation 98

Documentation Labelling 98

FDA Law Blog: Biosimilars

AUGUST 9, 2023

The transferring pharmacist must update the EPCS prescription record to note the transfer. The transferring or receiving pharmacy’s prescription processing software may, if capable, capture the required information from the EPCS and automatically populate the corresponding data fields documenting the transfer.

Controlled Substances 52

Controlled Substances Documentation Communication 52

pharmaphorum

SEPTEMBER 2, 2020

When changes occur, merge the changes, and update the annotations. If there are, once again you’ll need to merge them into the PDF document, update the annotations, and redo the bookmarks. There’s no need to redo bookmarks – this is done automatically! How can Formedix clinical trial automation software help? No worries.

Documentation 52

Documentation 52