In an era when the number of expedited and conditional review pathways for newly
available brand-name drugs and biosimilar medicines to treat serious and life-threatening …

Governance by the Backdoor: Administrative Law(lessness?) at the FDA Page 1 Lars Noah*
Governance by the Backdoor: Administrative Law(lessness?) at the FDA TABLE OF …

Background Given increasing community-based and off-label use of ketamine for psychiatric
indications, we examined current informed consent processes from a convenience sample …

I first wrote about opioid analgesics more than fifteen years ago.'After contrasting the clinical
mindset of the US Food and Drug Administration (FDA) with the law enforcement mentality of …

Background Improving safe and effective access to ketamine therapy is of high priority given
the growing burden of mental illness. Telehealth-supported administration of sublingual …

Background: Risk evaluation and mitigation strategies (REMS), as mandated by the US
Food and Drug Administration (FDA) for medications with the potential for harm, are …

INTRODUCTION Pharmaceutical approval today suffers from a serious ethical flaw: newly
FDA-approved drugs are de facto" tested" on an unknowing general public in the months …

Erythropoisis stimulating agent (ESA) use was addressed in Food and Drug Administration
(FDA) Oncology Drug Advisory Committee (ODAC) meetings between 2004 and 2008. FDA …

Background. While increasing evidence suggests that observers discount high-severity
chronic pain, factors that occasion such discounting are poorly understood, particularly …

The evolution of EU and US pharmacovigilance legislation highlights two trends. The first is
to strengthen the instruments of protection of human health through, inter alia, the …