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New Drug Applications produce new products - the lifeblood of the pharmaceutical industry. In addition to strong science, NDAs need effective Regulatory Affairs groups to help them navigate the regulatory labyrinth that is the U.S. Food and Drug Administration. To ensure successful interactions with the FDA, officials in Regulatory Affairs groups need to establish and cultivate both formal and informal relationships with agency officials.
This study examines what communication approaches foster effective relationships between Regulatory Affairs groups and the FDA and the importance of maximizing agency interactions. Additionally, this research explores valuable tactics for working with the FDA and the importance of understanding the Washington, D.C. ecosystem.
Regulatory leaders can use the insights from this research to inform their communication approaches with regulatory officials and to compare their group’s tactics for working with the agency on filings.
The research employed a data gathering approach that gleaned quantitative data from 15 biopharma companies and one medical device company through a detailed survey. In addition, 13 Regulatory leaders participated in in-depth interviews.