After sixteen years FDA has released a new draft guidance with updated regulations concerning the obtainment of informed consent from clinical trial subjects.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...
We are pleased to announce the hiring of Zac Unger as a Regulatory Analyst. Unger brings a strong blend of Information Technology (IT), document publishing, and software systems to the Pearl Pathways team. To read the full press release, click here.
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...
We invite you to join us at the second session of Indiana Medical Device Manufacturers Council (IMDMC)’s annual Regulatory 101 course on August 19, 2014. This is a popular event designed for staff who are new to the FDA regulatory world or those who just need a...
Pearl Pathways is pleased to announce the hiring of Heidi Hancock Strunk, RAC as a Regulatory Compliance Advisor. Strunk brings over twenty-three years of experience in FDA-regulated industries and thirteen years in management, including extensive expertise in the...
