News & Analysis as of

Manufacturers Rulemaking Process Proposed Rules

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

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

Pillsbury Winthrop Shaw Pittman LLP

EPA’s Wide-Ranging Rule on Perfluoroalkyl Substances

EPA continues its regulation of PFAS by shifting focus to the importation of certain PFAS-containing articles. - EPA goes for the low-hanging fruit by using TSCA to restrict the importation of long-chain PFAS that already...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

Dickinson Wright

Comments On NHTSA/EPA's Claim That Fuel Economy Standards Must Be Frozen to Save Lives

Dickinson Wright on

In a recent Client Alert, Will Increasing Fuel Economy Standards Really Make Cars Less Safe? NHTSA and the EPA’s Proposal to Freeze Fuel Economy Standards at 2020 Levels, I noted that NHTSA and the EPA have proposed freezing...more

Mintz

Proposal for FCC Rules for UAS Command and Control Spectrum

Mintz on

The Federal Communications Commission (FCC) is seeking public comment on a proposal by the Aerospace Industries Association (AIA) to adopt service rules for the use of 5030-5091 MHz by small Unmanned Aircraft Systems (sUAS). ...more

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