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Abstract

Vast amounts of scientific information and scientific-regulatory documentation are generated in the biopharmaceutical industry. The positive impact of recent technological advances on the creation, sharing, storage, compilation, and presentation of regulatory documentation is well recognized. In the United States, the ultimate customer and consumer of this myriad of information is the Food and Drug Administration (FDA), whose charter is to protect and advance the state of human health. There is a positive story to be told regarding the interactions between industry and the FDA which has led to hundreds of safe and effective, life-enhancing medical treatments being made available to the public. There is also a story within the story regarding how those parties working toward a common goal advanced the state of information exchange, from one that was totally paper based to one that now has the potential to become totally digital in format. The authors' intent is to recount that story and to provide evidence in support of the notion that refining the practice of digital information exchange will further streamline the regulatory review process.

Keywords

Computer-Assisted New Drug Applications (CANDAS)Adobe Acrobat Electronic regulatory submissions Publishing systems 1999 Guidance

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References

Dobbs

The CANDA: An Overview. In: Mathieu

, ed. CANDA: A Regulatory, Technology and Strategy Report. Waltham, MA: Parexel International Corporation; 1992:1–12.

Research Data Corporation. The CANDA and Third Party Vendors. In: Mathieu

, ed. CANDA: A Regulatory, Technology and Strategy Report. Waltham, MA: Parexel International Corporation; 1992:133–144.

The Division of Cardio-Renal Drug Products. CANDAs and FDA's Drug Review Divisions. In: Mathieu

, ed. CANDA: A Regulatory, Technology and Strategy Report. Waltham, MA: Parexel International Corporation; 1992:75–77.

The Division of Gastrointestinal and Coagulation Drug Products. CANDAs and FDA's Drug Review Divisions. In: Mathieu

, ed. CANDA: A Regulatory, Technology and Strategy Report. Waltham, MA: Parexel International Corporation; 1992: 87–88.

CANDA: A Regulatory, Technology and Strategy Report. Mathieu

, ed. Waltham, MA: Parexel International Corporation; 1992.

CANDA 1995: An International Regulatory and Strategy Report. Collins

, ed. Waltham, MA: Parexel International Corporation; 1994.

CANDA Guidance Manual. First Edition. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration: 1992.

CANDA Guidance Manual. Second Edition. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration: 1994.

Preface. In: Mathieu

, ed. CANDA: A Regulatory, Technology and Strategy Report. Waltham, MA: Parexel International Corporation; 1992.

10.

Leissa

CANDAs, the SMART Program, and the Year 2000. In Collins

, ed. CANDA 1995: An International Regulatory and Strategy Report. Waltham, MA: Parexel International Corporation; 1994: 78–82.

11.

Follow-ON CANDA Program Assessment. In: CANDA Guidance Manual. Second Edition, U.S. Department of Health and Human Services Public Health Service Food and Drug Administration: 1994: 43–50.

12.

Perdue

Laszlo

CANDA Technology and the Needs of Developers and Regulators of New Health-Care Products. In Collins

, ed. CANDA 1995: An International Regulatory and Strategy Report. Waltham, MA: Parexel International Corporation; 1994:216–232.

13.

Appendix 2: Example Content of Specific Clinical Datasets. In: Guidance for Industry Providing Regulatory Submissions in Electronic Format—NDA. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), IT 3; January 1999:70–74.

14.

What File Formats Should I Use for Electronic Documents? In: Guidance for Industry Providing Regulatory Submissions in Electronic Format—General Considerations. U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologic Evaluation and Research (CBER); January 1999:6–12.

15.

The Pilot Drug Division. CANDAs and FDA's Drug Review Divisions. In: Mathieu

, ed. CANDA: A Regulatory, Technology and Strategy Report. Waltham, MA: Parexel International Corporation; 1992: 91–93.

Regulatory Submissions: From CANDA/CAPLA to 2002 and Beyond

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