2015 top 10 women

Fierce Medical Devices announced the release of their list of top women in medical devices in 2015. The list is comprised of ten women across the nation of who have made an impact in the medical device industry this year. To access the article and list, click...

FDA developing regulations for NGS

The US Food and Drug Administration (FDA) is planning to develop ways to better determine accuracy of predictions from regulatory testing of next-generation sequencing (NGS), according to FDA Commissioner nominee Robert Califf. Michael Mezher states that FDA has been...

Pearl Pathways to expand into new market

Pearl Pathways is excited to announce its growth and expansion into a second location in College Station, Texas. The new office will be a part of The Garage, located within the Texas A&M Institute for Preclinical Studies (TIPS) building. The Garage is supported...

FDA must clarify flexibilities

The U.S. Food and Drug Administration (FDA) has been called by multiple organizations to clarify its “regulatory flexibility” with orphan drug reviews, according to Michael Mehzer, RAPS. FDA released a draft guidance in August addressing the most common issues faced...