News & Events

Pro Te: Solutio – Fall 2016

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices.

In EMA Guidance on Clinical Data Publication, we discuss recent guidance from the European Medicines Agency regarding publication of data from clinical trials. In particular, this article addresses how to achieve the goals of sharing clinical trial data to avoid duplication of effort, build public trust and assist researchers while also meeting the standards for privacy that are central to any clinical trial.

The Catch 22 of Crowdfunding for Medical Devices: Is it Pre-Selling? explores the impact and potential pitfalls of the use of crowdfunding to develop products that fall within the regulatory oversight of the FDA. This burgeoning area of public contribution to develop devices has not yet been the subject of FDA guidance, but its ever-increasing use demands special attention to FDA requirements.

European regulations are also addressed in Clinical Evaluations Reports: How to Leverage Published Data. Given the new guidance for such reports issued in 2016, completing such reports, overviewing content and methodology and leveraging that compilation of information are the focus here.

Our New and Noteworthy selection is legislation that is hot off the President’s desk. On December 13, 2016, President Obama signed the 21st Century Cures Act into law. We include some highlights from the sweeping legislation here, but plan to offer you a more in-depth look at this law and its developing impact in the future.

We hope that this exploration of regulatory guidance is useful to you as well as informative.

Download Issue: Pro Te Solutio Fall 2016, Vol. 9, No. 3

EMA Provides Long-Awaited Guidance Under The Policy On Publication Of Clinical Data – Pro Te Fall 2016

The Catch 22 Of Crowdfunding For Medical Devices: Is It Pre-selling? – Pro Te Fall 2016, by Dawn Norman

Clinical Evaluation Reports – How To Leverage Published Data – Pro Te Fall 2016, by Kim Strohkirch

The 21st Century Cures Act – Pro Te Fall 2016, by Kimberly S. Coggin