Pearls of Wisdom
Robert Seevers will speak about Good Distribution Practices to the Consumer Healthcare Products Association
Robert Seevers, Senior Advisor at Pearl Pathways, 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...
How to ask the FDA questions
In recent blog posts we have analyzed recent U.S. Food and Drug Administration (FDA) guidance topics regarding formal meetings with the FDA and best practices for communicating with FDA during drug development. One topic which we have not addressed is just...
The Strange Story of How the Orphan Drug Act Happened
For a long time, people spoke about the problems involved with delivering drugs to people with rare diseases. Development costs were high and regulatory hurdles even higher. Costs were not economically justified by the limited returns expected from a...
Gretchen Bowker, Diana Caldwell to deliver presentation for JLABS at TMC
Pearl Pathways co-founders, Gretchen Bowker and Diana Caldwell, 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,...
FDA expands guidance on pediatric drug development with new ICH E11(R1) Addendum
The United Stated Food and Drug Administration (FDA) implemented its version of the International Council for Harmonization’s (ICH) addendum on pediatric drug development, RAPS reports.¹ FDA added a considerable amount of new information to the policy...