Pearls of Wisdom
CBER, CDER issue data standards strategy through 2022
The Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) released the data standards strategy for 2018-2022 on Monday. The purpose of the CBER-CDER Data Standards Strategy is to reinforce the ongoing...
Medical device tax delayed for two years
Medical device companies collectively breathed a sigh of relief on Monday, January 22nd. Congress, as part of the stopgap spending bill, enacted a two-year delay on a 2.3 percent industry-wide excise tax. The tax officially began on December...
Annual “Day of Caring” event with Concord Neighborhood Center in Indianapolis
On Friday, January 19, 2018, we celebrated our annual Pearl Pathways "Day of Caring" event. Each year, we partner with a local organization in need to give back to the community. This year, Pearl partnered with Concord Neighborhood Center in downtown...
Former FDA regulatory scientist joins Pearl Pathways
Pearl Pathways is proud to announce the hiring of Robert Seevers, PhD as Senior Advisor. Seevers brings over 40 years of experience in pharmaceutical research and development for both large and small molecules. His expertise includes CMC regulatory, cold...
What is an FDA guidance document?
This is the first in a series of blog entries about U.S. Food and Drug Administration (FDA) guidance documents. As it happens, FDA has published a number of draft and final guidances in the past few months. We will provide an in-depth analysis of a few guidances that...