Patient safety

EMA revises guideline on first-in-human clinical trials

The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials. (Image: iStock/gcsherman)

The adapted guideline stresses a sponsor’s responsibility to define the uncertainty associated with the medicines tested in clinical trials.

Letters have been sent to the Appropriations Committees of the US Senate and the US House of Representatives, as well as to the US Food and Drug Administration (FDA) Commissioner. (Image: iStock/AlexRaths)

Compounding quality concerns: Legislation could 'fundamentally undermine' patient protections

Brexit is the process through which Britian may exit from the European Union (EU). (Image: iStock/Delpixart)

When, where, and how? Experts examine the current state of Brexit

The FDA's Expanded Access program provide patients with access to investigational drugs outside of a clinical trial. (Image: iStock/Berezko)

ACRO: Right to Try Act compromises clinical trial process

Researchers asked how patient preferences and burden of disease can be incorporated into randomized clinical trials (RCTs). (Image: iStock/BernardaSv)

Clinical trial study design: 'one size does not fit all'

Celerion adds biometric fingerprint tech across units

Celerion adds biometric fingerprint tech across units

Will deregulation trump clinical trial patient safety?

Will deregulation trump clinical trial patient safety?

(Image: iStock/BernardaSv)

Final Rule 'modernizes' protections for clinical trial participants

iStock/Melpomenem

Packaging design: how to ensure successful patient outcomes

Two more patients die in trial of Juno's JCAR015

Two more patients die in trial of Juno's JCAR015

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