In March 2020, Congress enacted the first Over-the-Counter (OTC) Monograph Drug User Fee program (OMUFA) as part of the CARES Act (P.L. 116 – 136) to modernize the Food and Drug Administration’s regulation of OTC monograph...more
On June 16, 2025, Senate Finance Committee Chairman Mike Crapo released text and a section-by-section summary of the Senate’s proposed One Big Beautiful Bill Act. The Senate passed a revised version of this measure on July 1,...more
7/7/2025
/ Budget Reconciliation ,
Congressional Budget Office ,
Federal Funding ,
Healthcare Reform ,
Medicaid ,
Medicare ,
Popular ,
Prescription Drugs ,
Senate Finance Committee ,
Tax Cuts and Jobs Act ,
Tax Reform ,
Trump Administration
On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more