Facilitating a More Efficient Commercial Review Process for Pediatric Drugs and Biologics
| Autor: | Mark A. Brown, Johanna Michelsohn, Joachim Storsberg, Aaron J Hosack, Kailee A Calder, Ryan D Rykhus, Christina Chang, Christian Schmidt, Aspen Turner, Benjamin H Markworth, Jacob M Berg, Kevin Alamo-Perez, Alix Young, Justin A Falk, Raegan Petch, Sarah M Dieker, Zachary V Shepard, Sydney R McAndrews, Hadley Frisby, Collin M Coon |
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| Přispěvatelé: | Publica |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Drug
Demographics Communication media_common.quotation_subject lcsh:R windfall tax lcsh:Medicine commercial drug approval 030204 cardiovascular system & hematology privatization Food and drug administration 03 medical and health sciences 0302 clinical medicine Biopharmaceutical industry Review process 030212 general & internal medicine Regulatory agency Business Marketing FDA media_common |
| Zdroj: | Diseases, Vol 6, Iss 1, p 2 (2017) Diseases |
| ISSN: | 2079-9721 |
| Popis: | Over 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. |
| Databáze: | OpenAIRE |
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