by Waylon Wright | Oct 5, 2017
Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA), an Outsourcing-Pharma.com article details. Recently, the appropriations...
by Waylon Wright | Sep 28, 2017
The new user fee deals have been signed into law. With the new deals, RAPS reports, come revised fee amounts from FDA for prescription drug and biosimilar applications and programs. FDA announced on Wednesday that the new fees will apply from October 1, 2017 through...
by Waylon Wright | Sep 26, 2017
Diana Caldwell, President and CEO of Pearl Pathways, will speak about entrepreneurship at the Healthcare Businesswomen’s Association– Indiana Chapter (HBA-IN) event, the Inaugural Healthcare Career Development Unconference. Diana will share details of her personal and...
by Waylon Wright | Sep 21, 2017
There is still time to register for the ACRP Circle City Chapter 17th Annual Fall Symposium occurring next Monday September 25, 2017. The symposium, titled “Excellence in Clinical Research 2017: Strategies to become a Great Site” will take place at the...
by Waylon Wright | Sep 18, 2017
FDA commissioner Scott Gottlieb plans to close a loophole currently allowing companies to avoid their obligation to study pharmaceuticals in pediatric populations. Gottlieb plans to close the loophole currently impacting pediatric clinical trials through a new...