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Early entrant protection in approval regulation : theory and evidence from FDA drug review

Carpenter, Daniel P.; Moffitt, Susan I.; Moore, Colin D.; … - In: The journal of law, economics, & organization 26 (2010) 3, pp. 515-545

Persistent link: https://www.econbiz.de/10008797710

Regulatory agency discretion among competing industries : inside the FDA

Olson, Mary K. - In: The journal of law, economics, & organization 11 (1995) 2, pp. 379-405

Persistent link: https://www.econbiz.de/10001193744

The distribution of surplus in the US pharmaceutical industry : evidence from paragraph iv patent-litigation decisions

Jacobo-Rubio, Ruben; Turner, John L.; Williams, Jonathan W. - In: The journal of law & economics 63 (2020) 2, pp. 203-238

Persistent link: https://www.econbiz.de/10012513603

Dealing with Excessive Off-label Drug Use: Liability vs. Patent Prolongation

Felder, Stefan; Olbrich, Anja - 2009

The US and the EU recently introduced regulation to curb the extent of risky off-label drug use. It offers manufacturers a prolongation of patent protection or exclusivity if they invest in pediatric clinical tests. This paper shows that a reinforcement of physician liability for off-label use...