On February 1, 2023, the U.S. International Trade Commission (the “ITC”) initiated an investigation into the impact of intellectual property (“IP”) rights on the production, supply, and availability of diagnostics and...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
5/11/2022
/ Biosimilars ,
BsUFA ,
CDRH ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Diversity ,
Drug Approvals ,
FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
GDUFA ,
Generic Drugs ,
Inspections ,
Labeling ,
Medical Device User Fee Program (MDUFA IV) ,
Misbranding ,
PDUFA ,
Pharmaceutical Industry ,
Popular ,
Waivers
On Saturday, March 6, 2021, by a vote of 50-49, the Senate amended and approved the American Rescue Plan Act of 2021, which is reconciliation legislation to provide $1.9 trillion in COVID-19 relief. The House of...more
3/11/2021
/ Affordable Care Act ,
American Rescue Plan Act of 2021 ,
Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
COBRA ,
Community Health Systems ,
Coronavirus/COVID-19 ,
Defense Production Act ,
Department of Health and Human Services (HHS) ,
FMAP ,
Medicaid ,
New Legislation ,
Provider Relief Fund ,
Relief Measures ,
Tax Credits ,
Unemployment Benefits ,
Vaccinations ,
Virus Testing
On June 5, 2020, President Trump signed into law the Paycheck Protection Program Flexibility Act, H.R. 7010 (P.L. 116-142). While this law does not add any new funding to the Small Business Administration (SBA) Paycheck...more
On March 18, President Trump signed into law H.R. 6201, the Families First Coronavirus Response Act (Public Law 116-127), a second coronavirus, or COVID-19, response package. Funds in the Act are designated as emergency...more
3/23/2020
/ Coronavirus/COVID-19 ,
EFMLA ,
Families First Coronavirus Response Act (FFCRA) ,
Family and Medical Leave Act (FMLA) ,
FMAP ,
New Legislation ,
PREPA ,
Relief Measures ,
Sick Leave ,
Sick Pay ,
Tax Credits
On March 6, 2020, President Trump signed H.R. 6074, the Coronavirus Preparedness and Response Supplemental Appropriations Act (the Act) into law (Public Law 116-123). The legislation, which was introduced on March 4 and...more