The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
6/20/2024
/ Artificial Intelligence ,
Biologics ,
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Healthcare ,
Laboratory Developed Tests ,
Legislative Agendas ,
Life Sciences ,
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Medical Devices ,
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Pharmaceutical Industry ,
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On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community.
Join us for insightful discussion about the latest regulatory and reimbursement developments....more
2/1/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Laboratory Developed Tests ,
Legislative Agendas ,
Medicare Administrative Contractors (MAC) ,
Prior Authorization ,
Regulatory Agenda ,
Reimbursements
The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more
1/12/2018
/ 21st Century Cures Act ,
Advertising ,
Digital Health ,
Executive Orders ,
FDARA ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Tobacco
On January 13, 2017, the US Food and Drug Administration (FDA) posted a “discussion paper” in which the agency outlines a substantially revised “possible approach” to the oversight of laboratory-developed tests (LDTs). The...more
Historically, the U.S. Food and Drug Administration (FDA) has exercised enforcement discretion with respect to most laboratory developed tests (LDTs) and has not required laboratories that furnish LDTs to comply with FDA’s...more