The Food and Drug Administration (FDA) approves vaccines when their benefits outweigh
the risks for their intended use. In this article we review the standard FDA approach to …

Context: New drug approvals in the United States must be supported by substantial
evidence from “adequate and well-controlled” trials. The Food and Drug Administration …

Introduction After the approval of a new drug, the Food and Drug Administration (FDA) may
issue postmarketing requirements (PMRs), studies that the law requires manufacturers to …

Reporting bias in clinical trials: Progress toward transparency and next steps | PLOS Medicine
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Importance In recent years, drug approvals have been based on fewer, smaller, and less
rigorous pivotal trials. Less robust preapproval testing raises questions about the efficacy …

Evidence at time of regulatory approval and cost of new antibiotics in 2016-19: cohort study of
FDA approved drugs - PMC Back to Top Skip to main content NIH NLM Logo Access keys NCBI …

Methods| This cohort study used Drugs@ FDA to identify FDA-approved novel drugs
between 2013 and 2016 and all reportable postmarket commitments (PMCs) and …

Abstract Introduction Since 2007, the US Food and Drug Administration has had the
authority to require risk evaluation and mitigation strategy (REMS) programs for certain …

PFS benefit# 2: PFS projects bring together new stakeholders to focus on a social problem,
forging a culture of collaboration in social services. The variety of stakeholders in a PFS …

Impact investing approaches, which deploy capital seeking both a financial return and a
social or environmental impact, have gained increasing attention and popularity …