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As the pharmaceutical industry makes its way into the digital age, a new initiative launched at UC San Diego hopes to guide ethics standards on the use of personal health data in clinical trials. Read More
The European Medicines Agency is moving to reject substitute proof-of-concept trials in place of GCP noncompliant studies during marketing application reviews. Read More
Health care advocates and drugmakers are hoping to build patient engagement into an earlier, more integrated and standardized part of clinical trials, amid a torrent of patient-centric efforts taking over the industry. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
All sponsors planning to conduct clinical trials in Saudi Arabia for the first time must register their studies through the Saudi Clinical Trials Registry, under new guidance released in late August. Read More
HHS on Sept. 2 proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials. Read More
Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers, investigators and clinical trials coordinators for conduct and data integrity violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued in early March by the Central Drugs Standard Control Organization. Read More