"The purpose of this guidance is to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA..
(photo credit: outsourcing-pharma.com)
“The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies..
"Companies that handle data are currently faced with constraints placed on them by data protection laws. The EU General Data Protection Regulation (GDPR) will come into effect on May of 2018 and..
"Whether you're an aspiring developer or an established one looking for a change, learning a programming language is a daunting task.
With an increase in demand for developers with statistical and..
PINEHURST (OCT. 2, 2017) — Forty North Carolina companies were honored on Monday, October 2 at Pinehurst Resort for being named as the N.C. Mid-Market Fast 40 list of 2017. Accounting firm Cherry..
"Jean Huddleston, MD, described how analytics can help hospitals recognize patterns and problems. But she also spoke to the challenges that new technologies face when vying for widespread adoption..
"RESEARCH TRIANGLE PARK, N.C. — Triangle Business Journal’s latest annual roundup of the 50 fastest-growing private companies in the Triangle region includes two bioscience companies and seven..
"Austin, TX – 07 SEP 2017 – The Clinical Data Interchange Standards Consortium (CDISC) and the Pharmaceutical Users Software Exchange (PhUSE) announced today an evolution of their partnership to..
(image credit: brinknews.com)
"With fines of up to 20 million euros ($23 million) or four percent of global annual turnover—which, for Fortune 100 companies, could reach billions of euros—and new..