Mar 5, 2024
In this episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in 2024 as it relates to clinical research. They discuss the significance of the decentralized clinical trials guidance documents, highlights of the Informed Consent Guidance...
Oct 12, 2023
In this episode, Alexa Sengupta and Cindy Ortega Ramos analyze the FDA’s latest guidance on informed consent regulations for clinical investigations. They discuss the basic elements of the consent form, documentation requirements for informed consent, and the impacts of the guidance for IRBs, clinical investigators,...
Jun 1, 2023
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials.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 trials, as well as notable planning considerations and regulatory requirements for both the industry...
Oct 28, 2021
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 day, and the action items health care providers should implement post-inspection.
Nov 12, 2020
In this week’s episode, Kenneth Kennedy discusses FDA’s ongoing focus on the issuance of warning letters to firms marketing fraudulent COVID-19 products, and to manufacturers who have failed to meet certain requirements under applicable FDA Emergency Use Authorizations (EUAs), as well as what manufacturers and...