Pearls of Wisdom
Congressional funding will help FDA update generic cancer drug labels
On June 18th, 2018 the US Food and Drug Administration (FDA) announced it would use congressional funding to update generic drug labels. Furthermore, FDA plans to begin with cancer drugs. In a blog post, FDA Commissioner Scott Gottlieb said the agency...
CPRIT announces new Seed Award for early-stage oncology startups
The Cancer Prevention and Research Institute of Texas (CPRIT) announces a new award targeting early-state oncology startups. The new grant mechanism, known as the Seed Award, allows companies to apply for up to $3 million in nondilutive funding to support...
FY 2018 Generic Drug Performance
With only three months remaining in Fiscal Year 2018, the US Food and Drug Administration (FDA) is on target to approve a similar number of generic drugs as it did in Fiscal 2017. Fiscal 2018 marks the first year of the agency’s second generic drug user fee program in...
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 at Pearl Pathways, 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, Robert Seevers will...