A new draft guidance issued by the U.S. Food and Drug Administration (FDA) provides advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials for cancer drugs and biologics. The draft guidance, issued in August 2018, describes the use...
Patti Connolly, Director of Clinical Services at Pearl Pathways, is a featured speaker at MAGI’s Clinical Research Conference – 2018 East. MAGI is an organization that aims to streamline clinical research by standardizing best practices for clinical...
Robert Seevers, Senior Advisor and Adjunct Board Member at Pearl IRB, will travel to Washington, DC May 17-18, 2018 to speak about Good Distribution Practices (GDP). Seevers will speak to the Consumer Healthcare Products Association (CHPA) on behalf of the United...
Pearl IRB co-founders, Diana Caldwell and Gretchen Bowker, have been invited to speak at the Johnson & Johnson Innovation center at the Texas Medical Center, also known as JLABS @ TMC. Bowker and Caldwell will speak to startup medical device, biopharma, and...
The United Stated Food and Drug Administration (FDA) implemented its version of the International Council for Harmonization’s (ICH) addendum on pediatric clinical trials and drug development, RAPS reports.¹ FDA added a considerable amount of new information to the...
