U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more
3/30/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Legislative Agendas ,
Proposed Legislation ,
Public Health Service Act ,
Regulatory Oversight
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more
12/28/2018
/ Center for Drug Evaluation and Research (CDER) ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Healthcare ,
Medical Devices ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Trump Administration
On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more
5/31/2018
/ 21st Century Cures Act ,
Administrative Reconsideration ,
Appeals ,
Biotechnology ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Oversight ,
Regulatory Standards