Jonathan P. Jarow
Food and Drug Administration
12 Papers
45 Citations
Jonathan P. Jarow is an academic researcher from Food and Drug Administration. The author has contributed to research in topics: Drug development & Medicine. The author has an hindex of 9, co-authored 12 publications.
Chat about Author
Papers
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
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,Michael A. O’Donnell,Diane Zipursky Quale,Mark P. Schoenberg,John D. Seigne,Bhadrasain Vikram +14 more
TL;DR: Expert commentary provided by panel members will inform a planned FDA guidance on pathways for drug and biologic development for NMIBC and will be discussed at meetings of the FDA's Oncologic Drugs Advisory Committee.
82
Medical devices: US medical device regulation
Jonathan P. Jarow,John H. Baxley +1 more
TL;DR: Medical devices are regulated by the US Food and Drug Administration within the Center for Devices and Radiological Health, which is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices.
65
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,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,Jonathan E. Rosenberg,Jonathan E. Rosenberg,Robert S. Svatek,Jeffrey S. Abrams,Hikmat Al-Ahmadie,Andrea B. Apolo,Joaquim Bellmunt,Margaret K. Callahan,Margaret K. Callahan,Eugene K. Cha,Charles G. Drake,Jonathan P. Jarow,Ashish M. Kamat,William Y. Kim,Margaret A. Knowles,Bhupinder Singh Mann,Luigi Marchionni,David J. McConkey,Lisa M. McShane,Nilsa C. Ramirez,Andrew B. Sharabi,Andrew B. Sharabi,Arlene H. Sharpe,David B. Solit,David B. Solit,Catherine M. Tangen,Abdul Tawab Amiri,Eliezer M. Van Allen,Pamela J. West,J.A. Witjes,Diane Zipursky Quale +40 more
- 27 Apr 2016
TL;DR: Two trial concepts emerged from the meeting including a window of opportunity trial testing an FGFR3 inhibitor and a second multi-arm multi-stage trial testing combinations of BCG or radiotherapy and immunomodulatory agents in patients who recur after induction BCG (BCG failure).
38
Partial Gland Ablation for Prostate Cancer: Report of a Food and Drug Administration, American Urological Association, and Society of Urologic Oncology Public Workshop.
TL;DR: The general consensus was that currently available technologies are capable of selective ablation with reasonable accuracy, but that criteria for patient selection remain debatable, and long-term cancer control remains to be established in properly designed and well-performed prospective clinical trials.
33
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 +5 more
TL;DR: This exploratory investigation of 1,492 hypogonadal men revealed considerable variation among individuals and target tissues in individuals, and suggested an approximate serum testosterone cutoff for normal of 300 ng/dl for percent change in hematocrit, and 200 ng /dl for baseline prostate specific antigen and percentchange in prostate specific antibody.
24