Sage Journals: Discover world-class research

Abstract

The Food and Drug Administration (FDA) has gained significant experience with computer-assisted licensing applications, and has concluded that continued reliance on customized formats is a burden for the FDA and industry. As a result, the FDA is working to standardize the content and format of electronically submitted applications, and to establish procedures for electronic applications that will: create minimal additional work for industry and reviewers, establish consistency across the FDA's centers, and expedite the review process. The FDA is proposing to move to a paperless regulatory process by the year 2002. Toward that goal, the FDA's Center for Biologics Evaluation and Research (CBER) has released new guidance for the electronic submission of biologic and product license applications; case report forms, tabulations, and statistical data; and lot release protocols. A pilot program for Investigational New Drug applications also has been initiated.

Keywords

Investigational New Drug;Biologic product license;Electronic;Guidance;CBER

Get full access to this article

View all access options for this article.

References

DIA-CDER Workshop: “Submissions in Electronic Format.” April 30, 1998, Washington, D.C. (Internet: www.fda.gov/cder/present/dia-498/index.htm).

Guidance for Industry: Electronic Submissions of Case Report Forms and Case Report Tabulations (draft),” November 1996. (Internet: www.fda.-gov/cber/guidelines.htm).

Guidance for Industry for the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description for Autologous Somatic Cell Therapy Products. Federal Register. January 10, 1997;62:1460–1461. (Internet: www.fda.gov/cber/guidelines.htm).

Guidance for Industry: For the Submission of Chemistry, Manufacturing, and Controls and Establishment Description Information for Human Plasma-Derived Biological Products or Animal Plasma or Serum-Derived Products. Federal Register. January 21, 1998;63:3145–3146. (Internet: www.fda.gov/cber/guidelines.htm).

Code of Federal Regulations. Food and Drugs, Title 21, part 314. Washington, DC: USG Printing Office, 1996.

Guidance for Industry: Electronic Submissions of Case Report Forms (CRFs), Case Report Tabulations (CRTs) and Data to the Center for Biologics Evaluation and Research. Federal Register. June 1, 1998;63:29739–29740. (Internet: www.fda.gov/cber/guidelines.htm).

Chew

Morgan

Wantowski

Taming the Paper Tiger at FDA. Appl Clin Trials. Feb. 1998; 36–40.

Guidance for Industry: A Pilot Program for Electronic Investigational New Drug (eIND) Applications for Biological Products. Federal Register. June 1, 1998;63:29740–29741. (Internet: www.fda.gov/cber/guidelines.htm).

Department of Health and Human Services.

Guidance for industry: “Providing Regulatory Submissions in Electronic Format-NDA.”

Federal Register. April 8, 1998;63:17184–17185. (Internet: www.fda.-gov/cber/guidelines.htm).

Submitting Biologics Applications to the Center for Biologics Evaluation and Research Electronically

Abstract

Keywords

Get full access to this article

References