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
On March 27, 2020, Congress passed the Coronavirus Aid, Relief and Economic Security (CARES) Act, which authorized $2.2 trillion to, among other things, help companies and individuals mitigate the financial repercussions...more
4/9/2020
/ Banks ,
Business Closures ,
Business Interruption ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Families First Coronavirus Response Act (FFCRA) ,
Federal Loans ,
Federal Reserve ,
Financial Stimulus ,
Health Care Providers ,
Healthcare ,
Lenders ,
Lending ,
Liquidity ,
Medicaid ,
Medicare ,
Nonprofits ,
Paycheck Protection Program (PPP) ,
Payroll Taxes ,
Relief Measures ,
SBA ,
SBA Lending Programs ,
Securities and Exchange Commission (SEC) ,
Small Business ,
Tax Relief ,
Unemployment Insurance
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 25, 2018, Associate Attorney General Rachel Brand issued a memorandum significantly restricting Department of Justice (“DOJ” or “the Department”) civil litigating units’ use of executive agency guidance documents...more