JonathanJarowMD

PubMed

• 8 citations
  Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence P...
  Chana Weinstock, Daniel L. Suzman, Paul G. Kluetz, John H. Baxley, Charles J. Viviano, Amna Ibrahim, Jonathan P. Jarow, Raejshwari Sridhara, Ke Liu, Peter R. Carroll, ...> ;The Journal of Urology. 2020 Jan 1
• 9 citations
  Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease
  Robert N. Schuck, Janet Woodcock, Issam Zineh, Peter Stein, Jonathan P. Jarow, Robert Temple, Thomas Permutt, Lisa M. LaVange, Julia A. Beaver, Rosane Charlab, Gideon ...> ;Clinical Pharmacology and Therapeutics. 2018 Aug 1
• 4 citations
  Personalized reproductive medicine: regulatory considerations.
  Jonathan P. Jarow> ;Fertility and Sterility. 2018 Jun 1
• 2 citations
  Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes?
  Elizabeth Richardson, Gregory W. Daniel, David R. Joy, Sandra L. Kweder, Diane M. Maloney, Miranda J. Raggio, Jonathan P. Jarow> ;Therapeutic Innovation & Regulatory Science. 2018 Apr 8
• 133 citations
  Multidimensional Evidence Generation and FDA Regulatory Decision Making: Defining and Using “Real-World” Data
  Jonathan P. Jarow, Lisa M. LaVange, Janet Woodcock> ;JAMA. 2017 Aug 22
• 9 citations
  Impact of Expanded Access on FDA Regulatory Action and Product Labeling.
  Jonathan P. Jarow, Richard Moscicki> ;Therapeutic Innovation & Regulatory Science. 2017 May 3
• Use of External Controls in Regulatory Decision-Making.
  Jarow, J. P.> ;Clin. Pharmacol. Ther.. 2017 Feb 10
• 9 citations
  Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials:
  Raymond P. Perez, Patrick Archdeacon, Nancy Roach, Robert Goodwin, Jonathan P. Jarow, Nina Stuccio, Annemarie Forrest> ;Clinical Trials. 2017 Mar 26
• 22 citations
  Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA's Role in Ensuring Patient Safety.
  Jonathan P. Jarow, Steven Lemery, Kevin Bugin, Naomi Lowy> ;Therapeutic Innovation & Regulatory Science. 2017 Mar 1
• 48 citations
  Overview of FDA's Expanded Access Program for Investigational Drugs.
  Jonathan P. Jarow, Peter Lurie, Sarah Crowley Ikenberry, Steven Lemery> ;Therapeutic Innovation & Regulatory Science. 2017 Mar 1
• 11 citations
  Precision medicine and the changing role of regulatory agencies.
  Alasdair Breckenridge, Hans-Georg Eichler, Jonathan P. Jarow> ;Nature Reviews. Drug Discovery. 2016 Oct 14
• 1 citations
  How much clinical evidence is enough: regulation of medical devices?
  Jonathan P. Jarow, Charles J. Viviano, John H. Baxley> ;Annals of Translational Medicine. 2016 Aug 24
• 49 citations
  Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period
  Jonathan P. Jarow, Steven Lemery, Kevin Bugin, Sean Khozin, Richard Moscicki> ;Therapeutic Innovation & Regulatory Science. 2016 Jun 29
• 19 citations
  The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative
  Jonathan P. Jarow, Sandra Casak, Meredith K. Chuk, Lori A. Ehrlich, Sean Khozin> ;Clinical Cancer Research. 2016 May 1
• 25 citations
  Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer
  Seth P. Lerner, Dean F. Bajorin, Colin P.N. Dinney, Jason A. Efstathiou, Susan Groshen, Noah M. Hahn, Donna E. Hansel, David J. Kwiatkowski, Michael A. O’Donnell, Jona...> ;Bladder Cancer. 2016 Apr 27
• 28 citations
  Partial Gland Ablation for Prostate Cancer: Report of a Food and Drug Administration, American Urological Association, and Society of Urologic Oncology Public Workshop.
  Jonathan P. Jarow, Hashim U. Ahmed, Peter L. Choyke, Samir S. Taneja, Peter T. Scardino> ;Urology. 2016 Feb 1
• 7 citations
  Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?
  Sean Khozin, Ke Liu, Jonathan P. Jarow, Richard Pazdur> ;Nature Reviews. Drug Discovery. 2015 May 22
• 12 citations
  Medical devices: US medical device regulation
  Jonathan P. Jarow, John H. Baxley> ;Urologic Oncology. 2015 Mar 1
• 15 citations
  Development of Systemic and Topical Drugs to Treat Non-muscle Invasive Bladder Cancer.
  Jonathan P. Jarow, V. Ellen Maher, Shenghui Tang, Amna Ibrahim, Geoffrey Kim, Rajeshwari Sridhara, Richard Pazdur> ;Bladder Cancer. 2015 Jan 1
• Reply by the authors.
  Jonathan P Jarow, Ian M Thompson> ;Urology. 2014 Sep 1
• Reply by the authors.
  Jonathan Jarow, Paul G Kluetz, Seth P Lerner, Ke Liu, Rajeshwari Sridhara, Dean Bajorin, Sam Chang, Colin P N Dinney, Susan Groshen, Michael O'Donnell, Diane Zipursky ...> ;Urology. 2014 Aug 1
• 10 citations
  Drug and device development for localized prostate cancer: report of a Food and Drug Administration/American Urological Association public workshop
  Jonathan P. Jarow, Ian M. Thompson, Paul G. Kluetz, John H. Baxley, Rajeshwari Sridhara, Peter T. Scardino, Peter R. Carroll, Peter C. Albertsen, H. Balentine Carter, ...> ;Urology. 2014 May 1
• 61 citations
  Clinical Trial Design for the Development of New Therapies for Nonmuscle-invasive Bladder Cancer: Report of a Food and Drug Administration and American Urological Asso...
  Jonathan P. Jarow, Seth P. Lerner, Paul G. Kluetz, Ke Liu, Rajeshwari Sridhara, Dean F. Bajorin, Sam S. Chang, Colin P.N. Dinney, Susan Groshen, Ronald A. Morton, Mich...> ;Urology. 2014 Feb 1
• 11 citations
  Variability of Semen Parameters with Time in Placebo Treated Men
  Jonathan P. Jarow, Xin Fang, Tarek A. Hammad> ;The Journal of Urology. 2013 May 1
• 14 citations
  Use of Biomarkers to Assess Tissue Specific Androgen Adequacy: Defining Male Hypogonadism
  Jonathan P. Jarow, John Troiani, Donald McNellis, Roger Wiederhorn, Guodong Fang, Harry Handelsman> ;The Journal of Urology. 2013 Feb 1
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