Companion on Drug Regulatory Submissions  (English, Paperback, Dr Dilpreet Singh)

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. The submission represents the tightest of bottlenecks in that development process: delays affect every other part of the operation, leading to criticism from clinical medical; 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.