Day: June 27, 2024

FDA inspections are intimidating events. The audited parties could intentionally or unintentionally behave in ways that are deemed as delaying, denying, limiting or refusing inspection by the FDA inspectors which are all illegal activities with serious consequences. Most of these issue emnate from the mispercetions regarding the rights of the audited parties during such audits. … Read more

If you think that the FDA is a “Black Box” where critical decisions are made in a subjective and opaque manner by a few powerful executives, you are not alone. Last week’s decision by the Director of the Center for Biologics at the FDA, Dr. Peter Marks, to expand the approval of Sarepta’s treatment for … Read more