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 18, 2017, the Food and Drug Administration (FDA or the Agency) released for public comment a Memorandum, Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding...more