A Process for Compliance with Revisions to FDA Regulations
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0092-8615/98 Copyright 0 1998 Drug Information Association Inc.
A PROCESS FOR COMPLIANCE WITH REVISIONS TO FDA REGULATIONS DAVIDW. JOHNSON, PHD Senior Regulatory Research Scientist, North American Regulatory Affairs
NIKOLACOLEMAN, RPH Regulatory Associate, Global Regulatory Operations
KRISTI KEPLER, PHARMD Visiting Regulatory Scientist, North American Regulatory Affairs
WAYNE
MILLAR,PHD
Senior Regulatory Research Scientist, North American Regulatory Affairs Eli Lilly & Co., Indianapolis, Indiana
Revisions to Food and Drug Administration (FDA) regulations occur periodically and f o r a number of reasons. Whenever such a change occurs, it is necessary for pharmaceutical companies to evaluate that change for its products and to set in motion the appropriate actions to comply with the change in the regulations, When a change affects many products from the same pharmaceutical company, there is a risk that the implementation actions will be inconsistent across products unless some standardized process is adopted. This paper discusses the internal process used at Eli Lilly and Company to achieve standardization and to comply with revisions in FDA regulations. This process is described in detail with respect to the recent revision to the Pediatric Use subsection regulations. A map of the process and an example of its use with a specific product are also given. Finally, the steps in the process that lend themselves to generalization of the process to other changes in the regulations are discussed. Key Words: Regulation revisions; Food and Drug Administration; Pharmaceutical products; Pediatric Use regulations; Implementation process
INTRODUCTION PERIODICALLY, FDA WILL revise certain sections of the Code of Federal Regulations (CFR)for prescription drugs and biologics to address unmet regulatory and/or medical needs, to clarify a section of the regulations that may be ambiguous, or to keep pace with the evolution of regulatory science. Some evolutionary changes are likely to stem from
Reprint address: b,David W, Johnson, pm, North American Regulatory Affairs, Drop Code 2543, Eli Ldly & Co., Indianapolis, IN 46285.
the adoption of more of the International Conference on Harmonization (ICH) initiatives and the consideration of the impact of those on the code. Other changes will arise directly from FDA initiatives. One such FDA initiated change was the recent change to the Pediatric Use subsection of the regulations. In preparing for implementation of this particular change for Eli Lilly and Company’s (Lilly) Indianapolis, Indiana marketed products, it was found that the process and procewith this dures put in place for regulation, many of which had been used for other regulation changes, but perhaps not
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standardized nor articulated clearly within the company, could be generalized to future revisions to the regulations. This paper describes in detail the process used for compliance with
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