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
Executive Order directs agencies to repeal rules and policies implementing regulatory reforms.
Included among the seventeen executive orders signed by President Biden on his first day in office was an order revoking six...more
The Issue: Federal agencies have issued subregulatory guidance affecting every industry during the COVID-19 pandemic.
The Situation: The federal government has issued executive orders and memoranda on the proper role of...more
The President issued an executive order directing agencies to address the economic impact of COVID-19 by eliminating regulations, providing reopening guidance to businesses, and recognizing that regulatory compliance can be...more
This action implements a portion of the President's recent Executive Order 13892, "Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication." In that Executive Order,...more
The president issued two executive orders limiting federal agencies' ability to use guidance documents for policymaking and enforcement and promoting transparency and fairness in civil enforcement matters....more
10/15/2019
/ Administrative Agencies ,
Administrative Proceedings ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Executive Orders ,
Fairness Standard ,
New Guidance ,
Regulatory Agencies ,
Regulatory Reform ,
Standard of Conduct ,
Transparency ,
Trump Administration