ABSTRACT

Regulatory Exclusivity Reform in the 115th Congress [September 15, 2017]   [open pdf - 762KB]

"Regulatory exclusivities provide incentives for pharmaceutical innovation in the United States. Overseen by the Food and Drug Administration (FDA), regulatory exclusivities are alternatively known as marketing exclusivities, data exclusivities, or data protection. Each of the distinct regulatory exclusivities establishes a period of time during which the FDA affords an approved drug protection from competing applications for marketing approval."

Report Number:
CRS Report for Congress, R44951
Author:
Publisher:
Date:
2017-09-15
Copyright:
Public Domain
Retrieved From:
Federation of American Scientists: http://www.fas.org/sgp/crs/index.html
Format:
pdf
Media Type:
application/pdf
URL:
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