Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using “Real-World” Data von Jarow, Jonathan P, LaVange, Lisa, Woodcock, Janet

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Precision medicine and the changing role of regulatory agencies von Breckenridge, Alasdair, Eichler, Hans-Georg, Jarow, Jonathan P.

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The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative von Jarow, Jonathan P, Casak, Sandra, Chuk, Meredith, Ehrlich, Lori A, Khozin, Sean

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Medical devices: US medical device regulation von Jarow, Jonathan P., M.D, Baxley, John H., M.S

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The Androgen Microenvironment of the Human Testis and Hormonal Control of Spermatogenesis von JAROW, JONATHAN P., ZIRKIN, BARRY R.

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Personalized reproductive medicine: regulatory considerations von Jarow, Jonathan P.

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Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety von Jarow, Jonathan P., Lemery, Steven, Bugin, Kevin, Lowy, Naomi

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Regulatory challenges of new male contraceptive methods von Sitruk‐Ware, Regine, Soule, Lisa, Jarow, Jonathan P., Odlind, Viveca

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Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period von Jarow, Jonathan P., Lemery, Steven, Bugin, Kevin, Khozin, Sean, Moscicki, Richard

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Overview of FDA’s Expanded Access Program for Investigational Drugs von Jarow, Jonathan P., Lurie, Peter, Ikenberry, Sarah Crowley, Lemery, Steven

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Best practice policies for male infertility von Sharlip, Ira D, Jarow, Jonathan P, Belker, Arnold M, Lipshultz, Larry I, Sigman, Mark, Thomas, Anthony J, Schlegel, Peter N, Howards, Stuart S, Nehra, Ajay, Damewood, Marian D, Overstreet, James W, Sadovsky, Richard

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Diagnostic Approach to the Infertile Male Patient von Jarow, Jonathan P., MD

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Regulatory watch: Why do oncology drugs fail to gain US regulatory approval? von Khozin, Sean, Liu, Ke, Jarow, Jonathan P, Pazdur, Richard

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Impact of Expanded Access on FDA Regulatory Action and Product Labeling von Jarow, Jonathan P., Moscicki, Richard

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Clinical Trial Design for the Development of New Therapies for Nonmuscle-invasive Bladder Cancer: Report of a Food and Drug Administration and American Urological Association Publi... von Jarow, Jonathan P, Lerner, Seth P, Kluetz, Paul G, Liu, Ke, Sridhara, Rajeshwari, Bajorin, Dean, Chang, Sam, Dinney, Colin P.N, Groshen, Susan, Morton, Ronald A, O'Donnell, Michael, Quale, Diane Zipursky, Schoenberg, Mark, Seigne, John, Vikram, Bhadrasain

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Partial Gland Ablation for Prostate Cancer: Report of a Food and Drug Administration, American Urological Association, and Society of Urologic Oncology Public Workshop von Jarow, Jonathan P, Ahmed, Hashim U, Choyke, Peter L, Taneja, Samir S, Scardino, Peter T

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Puboprostatic Ligament Sparing Improves Urinary Continence After Radical Retropubic Prostatectomy von Poore, Raymond E, McCullough, David L, Jarow, Jonathan P

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Simultaneous determination of steroid composition of human testicular fluid using liquid chromatography tandem mass spectrometry von Zhao, Ming, Baker, Sharyn D., Yan, Xiaohua, Zhao, Yiyu, Wright, William W., Zirkin, Barry R., Jarow, Jonathan P.

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Duplex ultrasonography detects clinically significant anomalies of penile arterial vasculature affecting surgical approach to penile straightening von Schaeffer, Edward M., Jarow, Jonathan P., Vrablic, Joseph, Jarow, Jonathan P.

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Insight on pathogenesis of varicoceles: Relationship of varicocele and body mass index von Nielsen, Matthew E., Zderic, Stephen, Freedland, Stephen J., Jarow, Jonathan P.

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