Companion on Drug Regulatory Submissions : Companion on Drug Regulatory Submissions

A formal submission to the United States Food and Drug Administration is a professionally frightening proposition. There is a great deal at stake: the submission can lead to permission to move forward with a drug development project with the promise of patient improvement and corporate profits. Thesubmission represents the tightest of bottlenecks in that development process: delays affect every other part of the operation leading to criticism from clinicalmedical; chemistry manufacturing and control testing ; and all other departments. And the submission response itself is open with blunt comments from a heartless agency widely distributed. Many a regulatory professional has lost sleep over the prospect of a major submission.