Jonathan P. Jarow
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View article: Regulatory challenges of new male contraceptive methods
Regulatory challenges of new male contraceptive methods Open
Introduction Progress in male contraception development faces the challenge of a lack of regulatory precedent and guidelines on the evidence (trial design and primary endpoint) required for marketing approval. Moreover, the development of …
View article: Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop
Development of Treatments for Localized Prostate Cancer in Patients Eligible for Active Surveillance: U.S. Food and Drug Administration Oncology Center of Excellence Public Workshop Open
The workshop provided an open forum for multiple stakeholder engagement to advance the development of effective treatment options for men with localized prostate cancer.
View article: Personalized reproductive medicine: regulatory considerations
Personalized reproductive medicine: regulatory considerations Open
View article: Impact of Expanded Access on FDA Regulatory Action and Product Labeling
Impact of Expanded Access on FDA Regulatory Action and Product Labeling Open
View article: Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials
Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials Open
Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reacti…
View article: Overview of FDA’s Expanded Access Program for Investigational Drugs
Overview of FDA’s Expanded Access Program for Investigational Drugs Open
View article: Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety
Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety Open
View article: How much clinical evidence is enough: regulation of medical devices?
How much clinical evidence is enough: regulation of medical devices? Open
In a recent publication, Marcus and colleagues questioned the adequacy of the amount of high level clinical evidence obtained under the current legal framework for U.S. regulation of medical devices (1). Based on a cross-sectional literatu…
View article: Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer
Summary and Recommendations from the National Cancer Institute’s Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer Open
The NCI Bladder Cancer Task Force convened a Clinical Trials Planning Meeting (CTPM) Workshop focused on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer (NMIBC). Meeting attendees included a broad and multi-disciplinary group of …
View article: Table of Contents
Table of Contents Open
View article: Development of Systemic and Topical Drugs to Treat Non-muscle Invasive Bladder Cancer
Development of Systemic and Topical Drugs to Treat Non-muscle Invasive Bladder Cancer Open
There are few approved drugs available for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) and none have been approved in the twenty-first century. Four drugs; thiotepa in 1959, BCG Tice in 1989, BCG Connaught in …