President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more
4/22/2019
/ Abbreviated New Drug Application (ANDA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Life Sciences ,
Manufacturers ,
MDRP ,
Medicaid ,
OIG ,
Prescription Drugs ,
Rebates ,
Section 340B ,
Trump Administration
Last week, the U.S. Food and Drug Administration (FDA) issued a final order classifying in vitro diagnostic (IVD) tests that utilize next generation sequencing (NGS) to profile cancer tumors into Class II (special controls)....more
On February 21, 2018, the Food and Drug Administration (FDA) issued a final rule amending the Agency’s regulations on acceptance of data from clinical investigations form medical devices. The final rule amends requirements...more