Berndt, Ernst R., Gottschalk, Adrian H. B., Philipson, Tomas, Strobeck, Matthew W.
Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within...
Berndt, Ernst R., Gottschalk, Adrian H. B., Philipson, Tomas, Strobeck, Matthew W.
Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within...
Berndt, Ernst R., Gottschalk, Adrian H. B., Philipson, Tomas, Strobeck, Matthew W.
Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within...
Berndt, Ernst R., Gottschalk, Adrian H. B., Philipson, Tomas, Strobeck, Matthew W.
Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within...
Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process
Ernst R. Berndt, Tomas Philipson, Matthew W. Strobeck
Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within...
Assessing the Safety and Efficacy of the FDA: The Case of the Prescription Drug User Fee Acts
Tomas J. Philipson, Ernst R. Berndt, Matthew W. Strobeck
The US Food and drug Administration (FDA) is estimated to regulate markets accounting for about 20% of consumer spending in the US. This paper proposes a general methodology to evaluate FDA policies,...
Ernst R. Berndt, Matthew W. Strobeck
In the United States, the Food and Drug Administration (FDA) agency is responsible for regulating the safety and efficacy of biopharmaceutical drug products. Furthermore, the FDA is tasked with...
BRG-1 is required for RB-mediated cell cycle arrest
Strobeck, Matthew W., Knudsen, Karen E., Fribourg, Anne F., DeCristofaro, Marc F., Weissman, Bernard E., Imbalzano, Anthony N., ...
The antiproliferative action of the retinoblastoma tumor suppressor protein, RB, is disrupted in the majority of human cancers. Disruption of RB activity occurs through several disparate mechanisms,...
BRG-1 is required for RB-mediated cell cycle arrest
Strobeck, Matthew W., Knudsen, Karen E., Fribourg, Anne F., DeCristofaro, Marc F., Weissman, Bernard E., Imbalzano, Anthony N., ...
The antiproliferative action of the retinoblastoma tumor suppressor protein, RB, is disrupted in the majority of human cancers. Disruption of RB activity occurs through several disparate mechanisms,...