Last Updated: 09/26/2026
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Found 28 publications
Regulatory challenges of new male contraceptive methods.
Journal: Andrology
Published: February 13, 2024
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.
Journal: The Journal of urology
Published: September 11, 2019
Impact of Expanded Access on FDA Regulatory Action and Product Labeling.
Journal: Therapeutic innovation & regulatory science
Published: August 07, 2018
Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes?
Journal: Therapeutic innovation & regulatory science
Published: May 02, 2018
Personalized reproductive medicine: regulatory considerations.
Journal: Fertility and sterility
Published: January 24, 2018
Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.
Journal: Clinical pharmacology and therapeutics
Published: December 13, 2017
Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA's Role in Ensuring Patient Safety.
Journal: Therapeutic innovation & regulatory science
Published: May 30, 2017
Overview of FDA's Expanded Access Program for Investigational Drugs.
Journal: Therapeutic innovation & regulatory science
Published: May 30, 2017
Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.
Journal: Clinical trials (London, England)
Published: March 28, 2017
Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period.
Journal: Therapeutic innovation & regulatory science
Published: December 06, 2016
How much clinical evidence is enough: regulation of medical devices?
Journal: Annals of translational medicine
Published: November 22, 2016
Last Updated: 09/26/2026