Paul Radensky, MD on Food and Drug Administration (FDA)

Federal Court Strikes Down LDT Final Rule

On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more

4/4/2025 / Administrative Law Judge (ALJ) , Appeals , Constitutional Challenges , Final Rules , Food and Drug Administration (FDA) , Judicial Review , Medical Devices , Regulatory Authority , Statutory Interpretation

CMS Releases Final Procedural Notice on Transitional Coverage for Emerging Technology (TCET)

The Centers for Medicare & Medicaid Services (CMS) issued the final procedural notice on Transitional Coverage for Emerging Technologies (TCET), effective as of August 12, 2024. TCET is a new pathway that uses existing...more

8/20/2024 / Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Insurance Industry , MACs , Manufacturers , Material Adverse Change Clauses (MACs) , Medicare , Public Comment , Technology Sector

FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices

On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as...more

5/1/2024 / Clinical Laboratories , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Manufacturers

Medicare Coverage of Wegovy Raises Questions Regarding the Affordability and Accessibility of Novel Medications

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they...more

3/28/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Material Adverse Change Clauses (MACs) , Medicare , Medicare Part B , Medicare Part D

Laboratory-Developed Tests: FDA Publishes Highly Anticipated Proposed Rule

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

10/5/2023 / CLIA , Clinical Laboratories , Diagnostic Tests , Food and Drug Administration (FDA) , Laboratory Developed Tests , Legislative Agendas , Life Sciences , Medical Devices , Proposed Regulation , Proposed Rules

CMS Releases Procedural Notice with Comment Period on Transitional Coverage for Emerging Technology

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a procedural notice with comment period on Transitional Coverage for Emerging Technologies (TCET), a new pathway that uses existing national coverage...more

6/28/2023 / Centers for Medicare & Medicaid Services (CMS) , Emerging Technologies , Food and Drug Administration (FDA) , Medical Devices , Medicare , New Guidance

[Event] +Dx Forum 2023 - March 3rd, Washington, DC

+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

[Event] Munich Life Sciences Bootcamp For In-House Counsel - November 21st, Munich, Germany

McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more

11/13/2019 / Data Protection , Digital Health , Events , Food and Drug Administration (FDA) , Germany , Health Care Providers , Health Technology , Healthcare , Life Sciences , Mobile Apps , Pharmaceutical Industry , Popular , Reimbursements , Technology Sector

FDA Creates Streamlined Review Pathway for Certain NGS-Based Tumor Profiling Tests

On November 15, 2017, the FDA announced the clearance of a tumor profiling test under a novel, streamlined FDA premarket review pathway for certain next generation sequencing (NGS)-based tumor profiling tests. The creation of...more

11/22/2017 / Food and Drug Administration (FDA) , Life Sciences

FDA Issues Draft Guidance on Payor Communications

Shortly after the recently enacted, bipartisan 21st Century Cures Act, which revised and expanded the extent to which specific health care economic information (HCEI) may be disseminated to certain stakeholders, and comes...more

2/2/2017 / Draft Guidance , Evidentiary Standards , Food and Drug Administration (FDA) , HCEI , Manufacturers , Pharmaceutical Industry

FDA Outlines Substantially Revised ‘Possible Approach’ to the Regulation of Laboratory-Developed Tests

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

1/26/2017 / Adverse Events , Analytics , Draft Guidance , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices

FDA Releases Long-Awaited Biological Naming Draft Guidance and Proposed Rule

On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more

9/10/2015 / Biologics , Biosimilars , Comment Period , Draft Guidance , Drug Safety , Federal Register , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Proposed Regulation , Public Health Service Act , World Health Organization

Anticipated Framework for Regulatory Oversight of Laboratory Developed Tests

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

8/7/2014 / CLIA , Clinical Laboratories , Food and Drug Administration (FDA) , Laboratory Developed Tests

Paul Radensky, MD

McDermott Will & Schulte

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