In response to FDA’s recent draft guidance on informed consent, industry affiliates such as the Association of Clinical Research Organizations (ACRO) and the Dana Farber Cancer Institute have provided detailed feedback in anticipation of the final guidance....
FDA has released a new final guidance document supporting clinical studies of new medical devices under their Investigational Device Exemption (IDE) regulations. In order to conduct clinical trials on investigational products, medical device companies must submit an...
Pearl Pathways’ own Gretchen Bowker will be speaking at the 2014 RAPS Preconference Workshop entitled Regulatory Strategy Forum for Biologics. She will be presenting at the 11am session on conducting clinical trials, which will cover the roles and...
In a study conducted by the Boston University School of Public Health (BUSPH), researchers found that nearly 30% of clinical trials completed in 2008 did not result in publication within four years. Additional evidence indicated a tendency for industry-funded clinical...
After sixteen years FDA has released a new draft guidance with updated regulations concerning the obtainment of informed consent from clinical trial subjects. The guidance begins by reiterating the basic process for obtaining consent, beyond written documentation. FDA...
The European Union (EU) recently published over 70 pages of legislation to conclude the long, exhaustive effort to remedy their old system of clinical trial regulations. Daniel Cressey’s article on nature.com highlights important takeaways from the legislation as well...
