Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical...more
5/30/2025
/ Asia Pacific ,
Australia ,
Centers for Medicare & Medicaid Services (CMS) ,
China ,
CLIA ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Laboratory Developed Tests ,
Medical Devices ,
Regulatory Reform ,
Singapore
In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more
1/22/2025
/ Clinical Trials ,
Draft Guidance ,
Drug Safety ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements