The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more
The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more
10/31/2023
/ Comment Period ,
FDA Approval ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform
Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more
The Texas Medical Board ("TMB") recently released proposed rules to implement Senate Bill 1107, which became law in May 2017 and allows for physician-patient relationships to be created solely through the provision of...more