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Environmental General Counsel PC

SB 54 _ California Selects CAA as PRO and Other Updates

Within the last month, California has made significant strides toward its bid to create a circular economy for certain packaging and food service ware materials. On January 8, 2024, California's Department of Resources...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

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

Sheppard Mullin Richter & Hampton LLP

FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”). The...more

Steptoe & Johnson PLLC

EPA Introduces Additional Action Items Under Its 2019 PFAS Action Plan

Steptoe & Johnson PLLC on

On January 19, 2021, the United States Environmental Protection Agency (“EPA”) introduced several new action items to further complement its progress under the 2019 Per-and Polyfluoroalkyl Substances ("PFAS") Action Plan....more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Sullivan & Worcester

PFAS Regulatory Update

Sullivan & Worcester on

As in previous postings, we discuss recent state regulatory initiatives aimed at addressing groundwater and drinking water contamination by per- and polyfluoroalkyl substances ("PFAS"). PFAS are a group of synthetic chemicals...more

Mintz - Health Care Viewpoints

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more

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