Microfiche and automated indexing applications for regulatory submissions to the Food and Drug Administration.

Abstract

In today's conservative climate, with cost-cutting consciousness, gradual steps should be taken to "marry" micrographics with new technologies. When managers have thorough knowledge and understanding of the regulatory requirements of the federal government, they can proceed to review, analyze and update documentation with indexing and decide the appropriate format of data, as well as the vehicles best suited for the user's needs, integrating micrographics and automated indexing. It is important that industry and regulatory agencies work together. For five years, Merck has been involved in refining microfiche specifications for submissions to various Bureaus at the Food and Drug Administration, originally for the Bureau of Drugs and currently for the Bureau of Foods and the Bureau of Veterinary Medicine. In these pilot projects, Merck has shared its know-how with other pharmaceutical companies in published articles, one-day seminars and several speeches at conferences of national organizations such as the Pharmaceutical Manufacturers Association (PMA) and the Association of Records Managers and Administrators (ARMA). In April 1979, a presentation was made before the Garden State Chapter of the National Micrographics Association (NMA).