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Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data

JAMA : the journal of the American Medical Association, 2017-08, Vol.318 (8), p.703

2017

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Precision medicine and the changing role of regulatory agencies

Nature reviews. Drug discovery, 2016-12, Vol.15 (12), p.805-806

2016

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The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative

Clinical cancer research, 2016-05, Vol.22 (9), p.2111-2113

2016

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Medical devices: US medical device regulation

Urologic oncology, 2015-03, Vol.33 (3), p.128-132

2015

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The Androgen Microenvironment of the Human Testis and Hormonal Control of Spermatogenesis

Annals of the New York Academy of Sciences, 2005-12, Vol.1061 (1), p.208-220

2005

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CHAPTER 1: THE MANAGEMENT OF ERECTILE DYSFUNCTION: AN AUA UPDATE

The Journal of urology, 2005-07, Vol.174 (1), p.230-239

2005

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Best practice policies for male infertility

Fertility and sterility, 2002-05, Vol.77 (5), p.873-882

2002

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Personalized reproductive medicine: regulatory considerations

Fertility and sterility, 2018-06, Vol.109 (6), p.964-967

Jarow, Jonathan P.

2018

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Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety

Therapeutic innovation & regulatory science, 2017-03, Vol.51 (2), p.246-249

2017

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Regulatory challenges of new male contraceptive methods

Andrology (Oxford), 2024-10, Vol.12 (7), p.1590-1599

2024

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Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period

Therapeutic innovation & regulatory science, 2016-11, Vol.50 (6), p.705-709

2016

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Overview of FDA’s Expanded Access Program for Investigational Drugs

Therapeutic innovation & regulatory science, 2017-03, Vol.51 (2), p.177-179

2017

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Diagnostic Approach to the Infertile Male Patient

Endocrinology and metabolism clinics of North America, 2007-06, Vol.36 (2), p.297-311

Jarow, Jonathan P., MD

2007

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Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?

Nature reviews. Drug discovery, 2015-07, Vol.14 (7), p.450-451

2015

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Impact of Expanded Access on FDA Regulatory Action and Product Labeling

Therapeutic innovation & regulatory science, 2017-11, Vol.51 (6), p.787-789

2017

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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 Public Workshop

Urology, 2014-02, Vol.83 (2), p.262-265

2014

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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

Urology, 2016-02, Vol.88, p.8-13

2016

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Puboprostatic Ligament Sparing Improves Urinary Continence After Radical Retropubic Prostatectomy

Urology (Ridgewood, N.J.), 1998, Vol.51 (1), p.67-72

1998

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Variability of Semen Parameters with Time in Placebo Treated Men

The Journal of urology, 2013-05, Vol.189 (5), p.1825-1829

2013

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Use of Biomarkers to Assess Tissue Specific Androgen Adequacy: Defining Male Hypogonadism

The Journal of urology, 2013-02, Vol.189 (2), p.633-637

2013

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Simultaneous determination of steroid composition of human testicular fluid using liquid chromatography tandem mass spectrometry

Steroids, 2004-10, Vol.69 (11), p.721-726

2004

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Duplex ultrasonography detects clinically significant anomalies of penile arterial vasculature affecting surgical approach to penile straightening

Urology (Ridgewood, N.J.), 2006, Vol.67 (1), p.166-169

2006

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Insight on pathogenesis of varicoceles: Relationship of varicocele and body mass index

Urology (Ridgewood, N.J.), 2006-08, Vol.68 (2), p.392-396

2006

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Low-Dose Human Chorionic Gonadotropin Maintains Intratesticular Testosterone in Normal Men with Testosterone-Induced Gonadotropin Suppression

The journal of clinical endocrinology and metabolism, 2005-05, Vol.90 (5), p.2595-2602

2005

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Drug and Device Development for Localized Prostate Cancer: Report of a Food and Drug Administration/American Urological Association Public Workshop

Urology, 2014-05, Vol.83 (5), p.975-978

2014

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Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using "Real-World" Data

Precision medicine and the changing role of regulatory agencies

The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative

Medical devices: US medical device regulation

The Androgen Microenvironment of the Human Testis and Hormonal Control of Spermatogenesis

CHAPTER 1: THE MANAGEMENT OF ERECTILE DYSFUNCTION: AN AUA UPDATE

Best practice policies for male infertility

Personalized reproductive medicine: regulatory considerations

Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety

Regulatory challenges of new male contraceptive methods

Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period

Overview of FDA’s Expanded Access Program for Investigational Drugs

Diagnostic Approach to the Infertile Male Patient

Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?

Impact of Expanded Access on FDA Regulatory Action and Product Labeling

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 Public Workshop

Partial Gland Ablation for Prostate Cancer: Report of a Food and Drug Administration, American Urological Association, and Society of Urologic Oncology Public Workshop

Puboprostatic Ligament Sparing Improves Urinary Continence After Radical Retropubic Prostatectomy

Variability of Semen Parameters with Time in Placebo Treated Men

Use of Biomarkers to Assess Tissue Specific Androgen Adequacy: Defining Male Hypogonadism

Simultaneous determination of steroid composition of human testicular fluid using liquid chromatography tandem mass spectrometry

Duplex ultrasonography detects clinically significant anomalies of penile arterial vasculature affecting surgical approach to penile straightening

Insight on pathogenesis of varicoceles: Relationship of varicocele and body mass index

Low-Dose Human Chorionic Gonadotropin Maintains Intratesticular Testosterone in Normal Men with Testosterone-Induced Gonadotropin Suppression

Drug and Device Development for Localized Prostate Cancer: Report of a Food and Drug Administration/American Urological Association Public Workshop

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