Importance US law requires testing of new drugs before approval to ensure that they provide
a well-defined benefit that is commensurate with their risks. A major challenge for the US …

The past decade witnessed rapid development of novel drugs and therapeutic biological
agents. The marketing authorization for novel therapies is often time consuming and …

Importance US law generally requires testing of high-risk medical devices prior to approval,
as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring …

Aims To identify, characterize and compare all Food and Drug Administration (FDA) and
European Medicines Agency (EMA) approvals that included real‐world data on efficacy from …

Research with human subjects 1 exemplifies the perennial conflict between the good of the
individual and the good of society. Policies and procedures that protect the rights and …

We develop an economic perspective on algorithmic fairness. Algorithmic bias and fairness
issues are appearing in an increasing variety of economic research literatures. Our …

Objectives Scalable informatics solutions that provide molecularly tailored treatment
recommendations to clinicians are needed to streamline precision oncology in care settings …

Background The COVID-19 outbreak is rapidly spread over the world and kills infected
patients. There is no proven medication for its treatment, so, all of the medications used for …

Raising the bar for using surrogate endpoints in drug regulation and health technology
assessment Page 1 Raising the bar for using surrogate endpoints in drug regulation and health …

Expanded access, also called “compassionate use,” provides a pathway for patients to gain
access to investigational drugs, biologics, and medical devices used to diagnose, monitor …