On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more
7/31/2020
/ Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Notice of Proposed Rulemaking (NOPR) ,
Prescription Drugs ,
Public Safety ,
State Implementation Plans (SIPs) ,
Trump Administration ,
Waivers
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
In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more
Program Has Broad Reach -
On October 21, 2016, the Food and Drug Administration launched a webpage that contains an Allegations of Regulatory Misconduct Form to enable whistleblowers, competitors, and others to report...more