Data Integrity

Boehringer Ingelheim Halts Development of HCV Treatment

Boehringer Ingelheim is halting development of deleobuvir-containing hepatitis C (HCV) drugs after Phase III clinical trial data showed the candidate lacked therapeutic value, clearing away one more candidate from the crowded field of new HCV treatments. Read More

Year in Review: Global Transparency Initiatives Dominate Busy 2013

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

Year in Review: Devicemakers Ride Regulatory Roller Coaster Into 2014

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