The Signaling Effects of the US Food and Drug Administration Fast-Track Designation

Author:

Miller Kathleen L.12,Nardinelli Clark1,Pink George2,Reiter Kristin2

Affiliation:

1. Office of Planning, Office of the Commissioner; US Food and Drug Administration; Silver Spring MD USA

2. Department of Health Policy and Management, Gillings School of Global Public Health; University of North Carolina at Chapel Hill; Chapel Hill NC USA

Publisher

Wiley

Subject

Management of Technology and Innovation,Management Science and Operations Research,Strategy and Management,Business and International Management

Reference46 articles.

1. Information asymmetry, R&D, and insider gains;Aboody;The Journal of Finance,2002

2. Administration, U.S. Food and Drug 2015 Number of Fast-track Designations Granted http://www.accessdata.fda.gov/FDATrack/track?program=cder&id=CDER-RRDS-Number-of-Fast-Track-Designations-granted&fy=all

3. Administration, U.S. Food and Drug 2012 Fast Track, Accelerated Approval and Priority Review http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

4. Wealth effect of drug withdrawals on firms and their competitors;Ahmed;Financial Management,2002

5. Prescription drug spending trends in the United States: looking beyond the turning point;Aitken;Health Affairs,2009

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