Executive Briefings

No Paper Trail in Drug Application Process, FDA Rules

If a semi-trailer truck filled with thousands of documents consistently showed up at your office for review, no one would question your sanity if you tried to put a stop to the practice. The U.S. Food and Drug Administration, the powerful government agency that controls the pharmaceutical industry, has decided to do just that by ending the practice of paper-based regulatory submission, which, in recent times, has generated a continuous tsunami of paper.
To do so, the FDA has mandated the electronic Common Technical Documents specification as the standard format for the submission of all new drug applications and supplements. The agency's decision, which went into effect at the beginning of this year, has increased pressure on life sciences and drug companies to comply by automating and streamlining their operations. U.S. drug manufacturers are scrambling to modify their document publishing and submission processes for compiling new drug submission data--originally designed for paper--so that they can submit product regulatory filings electronically to the FDA.
Source: Managing Automation

If a semi-trailer truck filled with thousands of documents consistently showed up at your office for review, no one would question your sanity if you tried to put a stop to the practice. The U.S. Food and Drug Administration, the powerful government agency that controls the pharmaceutical industry, has decided to do just that by ending the practice of paper-based regulatory submission, which, in recent times, has generated a continuous tsunami of paper.
To do so, the FDA has mandated the electronic Common Technical Documents specification as the standard format for the submission of all new drug applications and supplements. The agency's decision, which went into effect at the beginning of this year, has increased pressure on life sciences and drug companies to comply by automating and streamlining their operations. U.S. drug manufacturers are scrambling to modify their document publishing and submission processes for compiling new drug submission data--originally designed for paper--so that they can submit product regulatory filings electronically to the FDA.
Source: Managing Automation