In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more
6/1/2023
/ Biologics ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Centers ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
Regulatory Requirements ,
Scientific Research
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more
In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining...more
In this episode, Rebecca Schaefer and Victoria Hamscho discuss the impact of the ongoing COVID-19 pandemic on university research programs and public policy projections for a potential federal response. The presenters are...more
11/23/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Educational Institutions ,
Health and Safety ,
Infectious Diseases ,
Medical Research ,
Public Policy ,
Relief Measures ,
Remote Working ,
Research and Development ,
Universities