Medical Device Legal News with Sam Bernstein: Episode 11
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
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
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
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
The U.S. Food and Drug Administration (FDA) recently released draft guidance on how and when medical device manufacturers and pharmaceutical companies can respond to misinformation about their products online.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
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
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
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
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 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
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
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
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
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
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
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
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
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
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
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