pharmaphorum

FEBRUARY 23, 2021

IQWiG sees far less promise in other RWE sources such as electronic medical records and billing records of insurers. Figure 1: AMNOG procedures and findings, 2011-2019. Meanwhile, just like many countries, the Germans have seen the potential for savings from the use of biosimilars.

Biosimilars 90

Biosimilars Medical Records 90

FDA Law Blog: Biosimilars

MAY 13, 2024

Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making. Every use of ESD is recorded, as is every behavior that falls within the intended use.

Medical Records 111

Medical Records Documentation 111

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

However, the two previous FDA guidance documents, released in May 1998 ( Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products , available here ) and December 2019 ( Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products , available here ), differ from the new guidance.

Drug Development 64

Drug Development Documentation Labelling Medical Records 64