Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements -
In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more
Liability exposure and shields for vaccine developers -
As the number of COVID-19 cases continues to rise every day, efforts to develop vaccines across the globe have hit record speeds. In the U.S., the U.S. Food and Drug...more
5/28/2020
/ Center for Biologics Evaluation and Research (CBER) ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Investigational New Drug Application (IND) ,
National Institute of Health (NIH) ,
Popular ,
Professional Liability ,
Vaccinations ,
Virus Testing ,
World Health Organization
If Sustained, Court Decision Will Require Disclosure of Results for a Decade of Certain Clinical Trials -
Section 801 of the Food and Drug Administration Amendments Act of 2007 (“Section 801”), which is codified at 42...more
3/4/2020
/ Article III ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Federal Rule 12(b)(1) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Motion for Summary Judgment ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Preamble ,
Public Health Service Act ,
Retroactive Application ,
Rules of Appellate Procedure ,
Standard of Review ,
Standing
On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more
On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more
10/27/2016
/ Adverse Events ,
Civil Monetary Penalty ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Good Cause ,
Medical Devices ,
Penalties ,
Pharmaceutical Industry ,
Public Access Laws ,
Public Health Service Act