News & Analysis as of

Regulatory Agenda Draft Guidance Comment Period

DLA Piper

Navigating China's Healthcare Compliance Landscape: New Guidelines to Mitigate Commercial Bribery Risks

DLA Piper on

China's State Administration for Market Regulation (SAMR) has released the draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (Draft Guidelines) for public comment. The Draft Guidelines,...more

Troutman Pepper Locke

The Evolution of the FTC and DOJ Continues: Agencies Seek Public Comment on Draft Merger Guidelines

Troutman Pepper Locke on

The Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) jointly issued new draft Merger Guidelines on July 19. The draft Merger Guidelines were created with the goal "to better reflect how the agencies...more

Hogan Lovells

FDA seeks comment on food labeling information in e-commerce

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) is requesting comment on the availability of nutrition, ingredient, and allergen information online for packaged foods sold through online grocery shopping platforms.  FDA explains...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more

Stikeman Elliott LLP

Competition Bureau Publishes New Draft Enforcement Guidelines on Wage-Fixing and No Poaching Agreements

Stikeman Elliott LLP on

On January 18, 2023, the Competition Bureau published draft enforcement guidelines on wage-fixing and no poaching agreements, inviting interested parties to provide their comments no later than March 3, 2023. The draft...more

Hogan Lovells

FDA issues draft guidance on remote regulatory assessments

Hogan Lovells on

DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more

Foley Hoag LLP - Cannabis and the Law

Massachusetts Cannabis Control Commission Issues Draft Guidance on Hemp; Public Comments Accepted Through December 15

On November 23, 2021, the Massachusetts Cannabis Control Commission (CCC) released Draft Guidance on Hemp (Draft Guidance). Pursuant to a 2020 amendment, adult-use cannabis establishments licensed by the CCC are permitted...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

Hogan Lovells

DOJ and FTC extend deadline for public comments on draft vertical merger guidelines

Hogan Lovells on

The Federal Trade Commission (FTC) and Department of Justice (DOJ) have extended the deadline for public comments on the draft vertical merger guidelines (the Guidelines), which were published jointly by the agencies on 10...more

Epstein Becker & Green

A New Antitrust “Safety Zone” for Vertical Mergers

Epstein Becker & Green on

The U.S. Department of Justice and the Federal Trade Commission (collectively, “Agencies”) recently released for public comment their much-anticipated draft Vertical Merger Guidelines (“Guidelines”) that purport to “outline...more

Jones Day

Antitrust Alert: U.S. Antitrust Agencies Issue First Vertical Merger Guidelines in 35 Years

Jones Day on

Last week, the U.S. Department of Justice ("DOJ") and Federal Trade Commission ("FTC") issued draft Vertical Merger Guidelines. Vertical mergers combine two or more companies operating at different levels of a supply chain...more

Foley & Lardner LLP

FTC and DOJ Issue Draft Vertical Merger Guidelines

Foley & Lardner LLP on

On January 10, 2020, the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) released for public comment draft Vertical Merger Guidelines. Vertical mergers are those that combine companies...more

A&O Shearman

Five Key Aspects of the Long-Awaited Revised Draft US Vertical Merger Guidelines

A&O Shearman on

On Friday, the Federal Trade Commission (“FTC”) and the Antitrust Division of the U.S. Department of Justice (“DOJ”) released joint draft Vertical Merger Guidelines (“Guidelines”) for public comment. This much anticipated...more

Wilson Sonsini Goodrich & Rosati

FTC and DOJ Release Draft Vertical Merger Guidelines

On January 10, 2020 the United States Department of Justice (DOJ) and the Federal Trade Commission (FTC) released draft guidelines outlining the agencies' "analytical techniques, practices, and enforcement policy" for...more

Hogan Lovells

DOJ and FTC publish draft vertical merger guidelines

Hogan Lovells on

On Friday, 10 January 2020 the Department of Justice (DOJ) and Federal Trade Commission (FTC) (collectively, the agencies) announced the publication of draft vertical merger guidelines that describe how the agencies currently...more

Hogan Lovells

New draft guidance on MR compatibility for medical devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more

Hogan Lovells

The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more

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