That was because new drug applications range from 250,000 to 500,000 pages in length, and come from a myriad of sources—clinical trial studies, correspondence, manufacturing databases, the Patent Office, research lab notebooks, and the like. All this material has to be frozen in time as a master copy, against which all subsequent changes in information are posted and tracked. It is a nightmare of a problem, and it was costing the drug companies big bucks—basically one million dollars per day!
Talk about red tape. The FDA is going to read 500k pages for each page. Right.
