In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA.
Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more
Earlier this month, the FDA’s Center for Biologics Evaluation and Research issued its highly anticipated guidance outlining the agency’s current thinking on granting emergency use authorization (EUA) to investigational...more
10/29/2020
/ Biologics ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Interim Final Rules (IFR) ,
Investigational New Drug Application (IND) ,
Proposed Rules ,
Provider Relief Fund ,
Public Health Emergency ,
Vaccinations
After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine...more
Trends & Analysis:
..We have identified 33 health care–related qui tam cases that have been unsealed in whole or in part since the cases covered in our last Qui Tam Update. In addition, we have also identified one case...more