The Coalition for Clinical Trials Awareness (CCTA) has called for a federally-supported public health campaign to make people more aware of drug research and the value of participating in studies.
The Italian Ministry of Health has banned compounding pharmacies from preparing drugs containing any of seven APIs after chemists were discovered making dangerous off-label weight loss treatments.
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.
Agilent and A*STAR have partnered to create quicker, more accurate ways of testing the sugar content of therapeutic proteins and monoclonal antibodies (mAbs) that are tailored for commercial producers.
The use of substandard and falsified drugs in clinical trials has been neglected and new information on product quality should be included in the GCP (good clinical practice) guidelines from the WHO and ICH, academics contend in the British Medical Journal.
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.
India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill that would amend the country’s landmark law governing pharmaceuticals from 1940.
Indian regulators have accused a hospital of conducting unauthorised clinical trials of stem cell therapies and of charging patients who took part for the treatments.
Third-party logistics providers (3PLs) will have to report annually to the US FDA according to draft guidance published to help implement track and trace legislation.
CRO industry group ACRO has welcomed a US NIH draft policy promoting use of a single IRB for site reviews per institute-backed multi-centre study, arguing that the approach would accelerate trials without compromising safety.
The advent of Big Data in clinical trials will mean companies not using digital biomarkers are unlikely to exist by 2025, the President of cloud-based technology firm Medidata has warned.
The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies.
