India has created a formula to calculate the compensation clinical trial subjects will receive in the event of death or serious adverse event, stressing that sponsors must fully inform study subjects about the payments during a videotaped informed consent process. Read More

Doctors and researchers should have full access to clinical trial data on products licensed in the UK to ensure that the cost-benefits, as well as safety and efficacy, are considered in prescribing and coverage decisions, lawmakers say. Read More

EU lawmakers last month approved a compromise proposal for a new clinical trials regulation, paving the way for a March 10 plenary debate and adoption of a single regulatory framework for all 28 member states before upcoming May elections. Read More

The European Medicines Agency has postponed indefinitely a controversial transparency initiative that would make publicly available detailed information from clinical study reports contained in new drug applications. Read More

The push for trial data transparency — by regulators and pharma alike — kept sponsors and clinical sites on their toes in 2013. Both sides agreed that more transparency is needed, but they diverged on how to accomplish the goal. India announced new standards for ethics boards and patient compensation, while Japan’s Pharmaceutical and Medical Devices Agency launched an R&D and strategy consulting arm to fine-tune the development of novel products and speed regulatory approvals. Buzz words included “personalized medicine,” “enrichment trials” and “centralized monitoring.” Use this roundup of news highlights in 2013 to plan your clinical trial strategy for the year ahead. Read More

Lawmakers were closer to eliminating the 28 national clinical trial directives and establishing a single authorization procedure for all EU trials, following approval of draft language in December. Parliament is expected to take up the proposed clinical trial regulation during its March plenary session. Read More

Regulatory affairs folks had little time to relax in 2013, with heated debates over the future of EU device regulations, new controls in Japan and a proposed regulatory framework in India. And that’s just the tip of things. During the year, Malaysia got busy implementing its new device law and Brazil eased the process for device registration. Members of the International Medical Device Regulators Forum cemented plans for a January launch of a single-audit pilot program, and the U.S. Food and Drug Administration finalized rules for unique device identification. Use this review to reflect on developments in 2013 and prepare a winning business strategy in 2014. Read More

The Clinical Data Interchange Standard Consortium (CDISC) is asking for input on a new data submission standard that could give clinical trial sponsors and reviewers greater flexibility if adopted by the FDA for drug review applications. Read More

An overhaul of clinical trial regulations in the EU took a big step forward Dec. 20 as officials paved the way for revised rules to replace the current clinical trial directive in early 2014. Read More

An overhaul of clinical trial regulations in the EU took a big step forward Friday as officials paved the way for revised rules to replace the current clinical trial directive in early 2014. Read More

Clinical investigators in India must begin video recording the informed consent process for each study subject, the latest step in the government’s initiative to clean up the country’s troubled clinical trial industry. Read More