Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
AbstractOver the past two decades, the biopharmaceutical industry has seen unprecedented expansion and innovation in concert with significant technological advancements. While the industry has experienced marked growth, the regulatory system in the United States still operates at a capacity much lower than the influx of new drug and biologic candidates. As a result, it has become standard for months or even years of waiting for commercial approval by the U.S. Food and Drug Administration. These regulatory delays have generated a system that stifles growth and innovation due to the exorbitant costs associated with awaiting approval from the nation’s sole regulatory agency. The recent re-emergence of diseases that impact pediatric demographics represents one particularly acute reason for developing a regulatory system that facilitates a more efficient commercial review process. Herein, we present a range of initiatives that could represent early steps toward alleviating the delays in approving life-saving therapeutics. View Full-Text
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Rykhus, R.D.; Shepard, Z.V.; Young, A.; Frisby, H.; Calder, K.A.; Coon, C.M.; Falk, J.A.; McAndrews, S.R.; Turner, A.; Chang, C.; Michelsohn, J.; Petch, R.; Dieker, S.M.; Markworth, B.H.; Alamo-Perez, K.; Hosack, A.J.; Berg, J.M.; Schmidt, C.; Storsberg, J.; Brown, M.A. Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics. Diseases 2018, 6, 2.
Rykhus RD, Shepard ZV, Young A, Frisby H, Calder KA, Coon CM, Falk JA, McAndrews SR, Turner A, Chang C, Michelsohn J, Petch R, Dieker SM, Markworth BH, Alamo-Perez K, Hosack AJ, Berg JM, Schmidt C, Storsberg J, Brown MA. Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics. Diseases. 2018; 6(1):2.Chicago/Turabian Style
Rykhus, Ryan D.; Shepard, Zachary V.; Young, Alix; Frisby, Hadley; Calder, Kailee A.; Coon, Collin M.; Falk, Justin A.; McAndrews, Sydney R.; Turner, Aspen; Chang, Christina; Michelsohn, Johanna; Petch, Raegan; Dieker, Sarah M.; Markworth, Benjamin H.; Alamo-Perez, Kevin; Hosack, Aaron J.; Berg, Jacob M.; Schmidt, Christian; Storsberg, Joachim; Brown, Mark A. 2018. "Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics." Diseases 6, no. 1: 2.
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