New EU Clinical Trials Regulation

On 16 June 2014 a new Clinical Trial Regulation entered into force in Europe. It will apply no earlier than 28 May 2016.
The new regulation presents a major step forward in harmonizing clinical trial assessment process in the EU. For years, Europe was criticized for having too complicated, non-harmonized, nationally driven procedures for clinical trial assessment which often resulted in timely unpredictable and divergent assessment conclusions. Sponsors were faced with numerous country-specific protocol amendments as result of different opinions of one-country’s Competent Authority and Ethics Committee compared to opinions of other EU countries or even different opinions of Ethics Committee compared to national Competent Authority of the same country. In any case, Sponsors could expect any combination of decisions and close follow up by national experts was necessary.
[Read more...]

Controlling Compliance Risk in Global Clinical Research Activities

To say that globalization matters to pharmaceutical and medical device companies is an understatement. Labor, research, and payer coverage and reimbursement obstacles in North America and Europe, as well as increasing patent challenges, are forcing an intense focus on maximizing development activities and commercial opportunities around the world, including in jurisdictions that were barely on the radar screen in decades past. At the same time, speed to approval in developed markets remains critical, and a significant portion of the value proposition of research conducted in developing markets is often focused on support of approval applications in the US and EU, where the scrutiny of research and publication practices has steadily grown. Taken together, these trends require legal, regulatory, and compliance professionals to pay close attention to how clinical research activities are planned and executed.
[Read more...]

Beyond Gender Bias–Lessons from the Female Libido Drug’s Path To Approval

Female libido drug candidate flibanserin has rekindled a debate about gender bias in the Food and Drug Administration’s drug approval process. The debate centers on that agency’s approval of 24 drugs to treat male sexual dysfunction and its failure to approve even one drug to treat female sexual dysfunction. While commentators and politicians debate alleged gender bias at a federal agency headed by a woman, the flibanserin story provides important lessons for pharmaceutical and biotech companies that run into obstacles along the path toward approval.
[Read more...]