Blog
FDA discusses efforts to advance the patient voice in medical product development and regulatory decision-making
FDA Commissioner Scott Gottlieb, M.D., released a statement on June 12, 2018 discussing new agency efforts. Throughout the statement, Gottlieb acknowledges how biological advancements have led to the development and FDA approval of targeted treatments for...
Robert Seevers delivers supply chain control presentation at AFDO
Robert Seevers, Senior Advisor and adjunct Board member at Pearl IRB, will present at the 122nd AFDO Annual Educational Conference occurring in Burlington, VT on June 9-13. As a member of the USP Expert Committee on Packaging, Storage, and Distribution,...
Experienced biopharmaceutical and diagnostic leader joins Pearl Pathways
Pearl Pathways announces the hiring of Nancy Kant as Clinical Services Advisor to support biopharmaceutical and diagnostic life science companies. A skilled biologist, Kant brings over 35 years of experience in the pharmaceutical and diagnostics industries...
‘Right-to-try’ bill passes Congress: What you need to know
On May 22nd, the House voted to approve a version of “right-to-try” legislation. The bill passed by a vote of 250-169. The bill is intended to help patients with life-threatening conditions, allowing them to access medicines that the Food and Drug...
IRB Written Procedures Finalized
Institutional review boards were established to protect the rights and welfare of human research subjects. Review and approval by an IRB are necessary before human subject research can begin. Last week, the US Food and Drug Administration (FDA) and the...