PubMed Health⌕ Search

Biomedical subjects

Elizabeth A Spurgin

Publications and source records attributed to Elizabeth A Spurgin.

2 recordsLinked to original sources
PubMed2004

Planning for effective interaction with FDA.

Manufacturers of diabetes devices can facilitate the formal regulatory approval process through early interaction with the U.S. Food and Drug Administration (FDA). Effective planning can help manage commonly perceived risks of interaction with the Agency, introduce new technologies to regulatory reviewers, and inform the manufacturer's product development strategy. This article reviews key aspects of the FDA evaluation process and suggests strategies that may facilitate effective communication with the Agency. Integrating early communication with FDA into broader product commercialization planning can streamline regulatory review and lead to early product launch into reimbursed markets.

Aged↗
PubMed2004

Strategic planning for Medicare coverage and payment of new diabetes technologies.

This article reviews the process for gaining Medicare coverage and payment for new technologies and suggests factors to consider when developing a reimbursement strategy. Integrating Medicare reimbursement planning within the broader product commercialization strategy builds efficiencies and may enhance product uptake across both Medicare and private payer segments.

Aged↗