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Manufacturers Comment Period Regulatory Agenda

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Skadden, Arps, Slate, Meagher & Flom LLP

Commerce Department Seeks Comment on Restrictions on ‘Connected Vehicle’ Components From ‘Foreign Adversaries’

The U.S. Department of Commerce is soliciting comment on possible restrictions on “connected vehicle” components obtained from “foreign adversaries.” On March 1, 2024, the department’s Bureau of Industry and Security (BIS)...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

Robinson+Cole Manufacturing Law Blog

Covenants not to Compete: The End of an Era

On January 5, 2023, Federal Trade Commission (FTC) Chair Lina Khan announced a proposed federal regulation that, if enacted, would invalidate non-competes and similar restrictive covenants that are routinely used by companies...more

Robinson+Cole Manufacturing Law Blog

SEC Proposed Rule on Climate-Related Disclosures: A Look at Scope 3 Emissions Reporting Requirements

True to its word, the SEC released its proposed rule, The Enhancement and Standardization of Climate-Related Disclosures for Investors, last week. The rule would require companies to disclose a wide variety of climate-related...more

BCLP

Federal PFAS Development: Preliminary Effluent Guidelines Program Plan 15

BCLP on

The United States Environmental Protection Agency (“EPA”) has outlined additional steps that it plans to take to investigate and in some cases regulate the discharge of per- or polyfluoroalkyl compounds (“PFAS”) in certain...more

Stinson LLP

FDA Proposes (Again) to Amend the "Intended Use" Regulation

Stinson LLP on

This week, FDA published a proposed rule that would amend its medical product "intended use" regulations, 21 CFR §§ 201.128 and 801.4 and replace the 2017 Final Rule about the same issue that never became effective....more

Hogan Lovells

EU Commission seeks feedback on implementing the new Market Surveillance Regulation

Hogan Lovells on

The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more

Robinson+Cole Manufacturing Law Blog

PFAS Update: EPA Progress Under PFAS Action Plan

Earlier this year, we wrote about EPA’s PFAS Action Plan, the agency’s blueprint for addressing contamination and protecting public health from per- and polyfluoroalkyl substances (PFAS). ...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

Robinson+Cole Manufacturing Law Blog

New DOL Overtime Rule Impacts Manufacturers

The United States Department of Labor finally published its proposed regulation raising the minimum salary to be paid under the “white collar” exceptions to the Fair Labor Standards Act....more

Stoel Rives - Environmental Law Blog

What You Need to Know about the Proposed Revisions to Cap and Trade

Late Tuesday, the California Air Resources Board (ARB) released draft amendments to the state’s cap and trade regulation, including revisions to the current program in place through 2020, an extension of the program through...more

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