AbbVie VP of Oncology Discovery Steve Davidsen, Ph.D. is a living, breathing timeline of the company's cancer research and development efforts. He's charted the adoption of multiple advanced technologies that have contributed to the realization of dozens of molecular weapons in the fight against cancer. On the Business of Biotech, Dr. Davidsen shares the latest on AbbVie's adoption of computational biology and how it's contributing to discovery and development efficiencies. Listen now.
The FDA will issue a Form 483 for noncompliance in the software validation GxP environment, mostly due to data integrity failures, inadequate written procedures, deficiencies in investigations, and substandard laboratory controls.
By Mike Trinks, Fiondella, Milone & LaSaracina LLP
You've finally received the grant you need to make your biopharma business a reality. The tough part is over, right? Not exactly. If you mismanage your funds, you could end up on the government’s naughty list.