The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
1/10/2023
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
BsUFA ,
Clinical Trials ,
Cosmetics ,
Disclosure Requirements ,
Diversity and Inclusion Standards (D&I) ,
DSHEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GDUFA ,
Inspections ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
Misbranding ,
Opioid ,
Orphan Drugs ,
Over The Counter Drugs (OTC) ,
PDUFA ,
Public Health ,
Real World Evidence ,
User Fees
On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more
6/2/2022
/ Animal Testing ,
BsUFA ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
DSHEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GDUFA ,
HELP ,
Manufacturers ,
Medical Device User Fee Program (MDUFA IV) ,
PDUFA ,
PFAS ,
Prescription Drugs ,
Public Health ,
Public Health Service Act ,
Purple Book ,
REMS ,
Title III
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
On May 23, 2019, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) and Patty Murray (D-WA) released the Lower Health Care Costs Act of 2019 – bipartisan draft legislation to reduce...more
5/30/2019
/ Congressional Committees ,
Congressional Investigations & Hearings ,
Drug Pricing ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Healthcare ,
Healthcare Costs ,
Prescription Drugs ,
Proposed Legislation ,
Public Health ,
Surprise Medical Bills ,
Transparency
Several House and Senate committees are examining various legislative solutions as part of a comprehensive effort to address the opioid crisis. In one such instance, the House Energy and Commerce Health Subcommittee last week...more
Yesterday, by a vote of 217 to 213, the U.S. House of Representatives approved H.R. 1628, the American Health Care Act (AHCA), to repeal and replace the Patient Protection and Affordable Care Act (ACA). The House action...more