FDA staff can share information and review documents in minutes versus days, and the huge volumes of data are easier to manage and archive. Drug companies can release promising medications sooner, possibly increasing their daily revenues by millions of dollars. Consumers get faster access to breakthrough medications.
Taxpayers get a more efficient government agency.
Pharmaceutical companies submit thousands of NDAs annually to the FDA, with the hope of introducing new drugs, changing recommended dosages, or marketing medications for different therapies. A typical NDA contains extensive pharmacology reports and results from clinical trials, often bound in as many as 1,000 volumes with 300 pages each - submitted in triplicate. Economic advantages In late 1997, the FDA started giving pharmaceutical companies the option of submitting their NDAs as PDF files. Since then, the agency has received PDF submissions totalling more than 7 million pages. All rights reserved.