Patient centricity

WuXi finds success in pilot testing of edible microtags

WuXi finds success in pilot testing of edible microtags

By Zachary Brennan

Service provider and contract manufacturer WuXi PharmaTech is vouching for TruTag Technologies’ edible microtags following a pilot project adding to evidence that they can help root out counterfeits.

China is looking to amend its GCP and bring more of the clinical trial industry up to speed

Amended Chinese GCP could aid development of CRO industry

By Zachary Brennan

The China Food and Drug Administration (CFDA) is proposing to amend its GCP (good clinical practices) to add more specific responsibilities for sponsors, Ethics Committees (ECs) and sites as part of efforts to further protect study subjects, experts say.

Review finds falsified electrocardiograms by 10 different employees at GVK

Update

EMA opens investigation into India’s GVK Bio over ECG falsifications

By Zachary Brennan

At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified electrocardiograms in all nine clinical trials evaluated. 

French regulator raises concerns over Indian CRO studies

French regulator raises concerns over Indian CRO studies

By Zachary Brennan

Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical practice) inspection citing deficiencies in the...

Concerns raised over FDA’s informed consent draft guidance

Concerns raised over FDA’s informed consent draft guidance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The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what the revisions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.

EU MEPs plan to make drugmakers upload trial data to public database

breaking news

EU MEPs plan to make drugmakers make trial data public

By Gareth Macdonald

Drugmakers and academics will have to upload the results of trials run in Europe to a public database under a provisional deal agreed in the European Parliament earlier today.