News & Analysis as of

Comment Period New Guidance Supply Chain

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Robinson+Cole Health Law Diagnosis

DOJ and FTC Announce Draft Vertical Merger Guidelines

On January 10, 2020, The Department of Justice (DOJ) and Federal Trade Commission (FTC) announced new draft vertical merger guidelines for public comment. The draft guidelines (once finalized) will replace the DOJ’s 1984...more

Perkins Coie

US DOJ and FTC Propose Vertical Merger Guidelines

Perkins Coie on

The U.S. Department of Justice and U.S. Federal Trade Commission published proposed vertical merger guidelines (vertical guidelines) on January 10, 2020. These are designed to increase the transparency of the agencies'...more

King & Spalding

DOJ and FTC Release New Vertical Merger Review Guidelines for Public Comment

King & Spalding on

On Friday, January 10, the Department of Justice’s Antitrust Division and the Federal Trade Commission issued new guidelines for the agencies’ review of vertical mergers. Vertical mergers involve the combination of firms...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

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