Patient safety

Concerns raised over FDA’s informed consent draft guidance

Concerns raised over FDA’s informed consent draft guidance

By Zachary Brennan

The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what the revisions didn’t include.

CDSCO issues raft of new trial regulations

CDSCO issues raft of new trial regulations

By Gareth Macdonald

Sponsors and CROs must ensure that clinical studies are properly designed and that investigators work on a maximum of three trials simultaneously under new guidelines issued by Indian regulators.

IOM looks into new ways to share clinical trial data

IOM looks into new ways to share clinical trial data

By Zachary Brennan

The Institute of Medicine is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data before a final report is released in December 2014.