In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials.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Draft Guidance ,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 week’s episode, Richard Church interviews Michael Hinckle about FDA inspections of health care providers. They discuss why an inspection might come up, what providers should expect, the do’s and don’ts of inspection...more
This final article in our four-part series examines other relevant laws digital health providers and suppliers should know. If you missed our earlier articles, you can read about HIPAA in Part I and Part II, and the FDCA and...more
This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to non-US companies. ...more
Digital health technologies are revolutionizing the global health environment by advancing healthcare services, Big Data analytics and medical device development and innovation, expanding the reach, accessibility and...more
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this...more