News & Analysis as of

Enforcement Draft Guidance

Latham & Watkins LLP

A Less Economic Approach? European Commission Consults on Draft Guidelines for Exclusionary Conduct

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The European Commission (EC) has published draft antitrust guidelines on exclusionary abuses (the Draft Guidelines) and is conducting a public consultation to gather feedback....more

White & Case LLP

The European Commission moves away from economics and proposes a presumption-based approach in its draft guidelines on...

White & Case LLP on

The European Commission has published for public consultation its long-awaited draft Guidelines on exclusionary abuses (draft Guidelines). The draft Guidelines aim at making it faster and easier for the Commission to pursue...more

A&O Shearman

From effects to presumptions? The EC Draft Guidelines on exclusionary abuse

A&O Shearman on

The Draft Guidelines set out the European Commission (EC)’s approach on exclusionary abuse by dominant undertakings. The EC is proposing a shift away from the effects-based approach set out in its earlier enforcement...more

Gardner Law

FDA Drafts Guidance on Correcting “Misinformation”

Gardner Law on

The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online. While not yet...more

Foley Hoag LLP

Want to Say It Ain't So? FDA Guides Firms on How to Respond to Misinformation

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Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more

King & Spalding

FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

King & Spalding on

On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more

Mitchell, Williams, Selig, Gates & Woodyard,...

FY 2025-2026 Draft National Program Guidance/U.S. EPA Office of Enforcement and Compliance Assurance: National Association of...

The National Association of Clean Air Agencies (“NACAA”) sent a June 10th letter to the United States Environmental Protection Agency (“EPA”) providing comments on the federal agency’s FY 2025-2026 National Program Guidance...more

Dechert LLP

Dechert Cyber Bits - Issue 54

Dechert LLP on

European Data Protection Board Publishes Strategy for 2024-27 - The European Data Protection Board (“EDPB” - the EU body tasked with promoting consistency and cooperation in enforcement of the GDPR) has outlined its...more

Skadden, Arps, Slate, Meagher & Flom LLP

As US Antitrust Agencies Double Down on Merger Enforcement Approach, New Deal Strategies Emerge

Key Points - - New draft merger guidelines reflect the aggressive approach that has defined merger enforcement in the Biden administration, including novel theories of harm. - Proposed changes to HSR notification will make...more

TransPerfect Legal

Unpacking the Latest Regulatory Trends in U.S. Second Requests

TransPerfect Legal on

TransPerfect Legal held its third annual Antitrust Clearance & Merger Enforcement Conference on October 24, 2023, in New York City. At the conference, antitrust experts from across the country participated in six...more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q3 2023

Goodwin on

The FTC’s Amgen/Horizon Lawsuit Ends With a Whimper - We covered the FTC’s investigation into (and litigation challenging) Amgen’s $28.3 billion acquisition of rare disease specialist Horizon Therapeutics in our Q1 and...more

King & Spalding

FTC and DOJ Announce New Draft Merger Guidelines

King & Spalding on

vOn July 19, 2023, the U.S. antitrust enforcers, the Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) (collectively, the “Agencies”), released draft merger guidelines for public...more

Axinn, Veltrop & Harkrider LLP

Axinn Antitrust Insight: New Proposed Merger Guidelines Reflect DOJ and FTC’s Anti-merger Policy, Signal Continued Aggressive...

The U.S. Department of Justice, Antitrust Division (DOJ), and the Federal Trade Commission (FTC) (and together, the “Agencies”) have released long-anticipated draft merger guidelines (the “2023 Draft Guidelines”) that...more

Proskauer - Law and the Workplace

AI-Based Discrimination Top of the EEOC’s Draft Enforcement Plan

The Equal Employment Opportunity Commission (“EEOC”) has started 2023 with an announcement that it intends to increase enforcement efforts aimed at discrimination resulting from the use of Artificial Intelligence assisted...more

King & Spalding

FDA Issues Draft Guidances on Transitioning Devices from EUAs and Agency Enforcement Policies

King & Spalding on

During the ongoing COVID-19 pandemic, the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA or the Agency) issued a series of Emergency Use Authorizations (EUAs) and guidance...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Help Make More Ventilators Available

Seyfarth Shaw LLP on

The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more

Skadden, Arps, Slate, Meagher & Flom LLP

FTC and DOJ Release Draft Vertical Merger Guidelines

As anticipated, on January 10, 2020, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) (collectively, the Agencies) released Draft Vertical Merger Guidelines (Draft Guidelines), marking the first update...more

Mintz - Consumer Product Safety Viewpoints

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

Foley & Lardner LLP

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

Foley & Lardner LLP on

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

Patterson Belknap Webb & Tyler LLP

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

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