Blog
New EMA guideline on first-in-human clinical trials slated for 2018
The European Medicine Agency’s new guideline focuses on a sponsor’s responsibility to define the uncertainty associated with the medicines tested in clinical trials. The announcement occurred last week and the EMA guideline will go into effect on January...
Live webinar covering Japanese medical device approvals from Pearl IRB partner, Brandwood Biomedical- August 15th
On August 15th, join our partner Brandwood Biomedical to learn about the Japanese regulatory process. Prior to the internationally harmonized Japanese Pharmaceutical and Medical Devices Law, the process may have seemed obscure but things aren’t as complex as you may...
How FDA listens to the voice of patients
The Food and Drug Administration (FDA) vows to never forget that their efforts to evaluate and approve new medical products is done to benefit patients. Because of this they are constantly looking to find new ways to incorporate the views and expertise of patients and...
New Guidance Issued on Informed Consent Waivers for Minimal Risk Studies
The US Food and Drug Administration (FDA) on Monday, July 24 issued guidance detailing the circumstances to which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants, according...
Site Selection Tips
Kunal Sampat, MNA, senior manager for Clinical Trial Programs at Abbott Vascular believes that data should lead the way it comes to site selection. He says, “let data drive your site selection decisions” and “don’t support lousy site seletion.”1 His other tips...