FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements. We should explain what RIEs are.

Documentation 105

Documentation Medical Records 105

pharmaphorum

SEPTEMBER 16, 2021

Promoting automatic substitution of, for example, biosimilars on formularies and registers could accelerate conversion to use of biosimilars, releasing significant financial savings. But in some areas of prescribing national leadership is needed to accelerate and support local systems’ medicines optimisation efforts.

Biosimilars 113

Biosimilars Community Pharmacies Medical Records Documentation 113

FDA Law Blog: Biosimilars

MAY 13, 2024

This guidance, when finalized, will replace the original version of this document finalized in 2017. There is ample data collected on them during this 24/7 monitoring period such as case notes, contemporaneous patient medical records, and patient tapes. Patients that use ESD undergo continuous 24/7 monitoring.

Medical Records 111

Medical Records Documentation 111

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. objective clinical outcomes in the context of detailed medical record collection).

Drug Development 64

Drug Development Documentation Labelling Medical Records 64