Medical Device Legal News with Sam Bernstein: Episode 11
On August 21, Oregon’s Prescription Drug Affordability Board (PDAB) reviewed a draft upper payment limit (UPL) constituent engagement report, which captured feedback from patients, providers, health plans, manufacturers, and...more
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more
On July 16, 2024, the California Privacy Protection Agency (the “CPPA”) board declined to advance to formal rulemaking California Consumer Privacy Act (“CCPA”) draft regulations on cybersecurity audits, risk assessments,...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
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions....more
On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more
Article 5(3) of the EU ePrivacy Directive (ePD) requires consent for tracking cookies (unless exceptions apply). Although this rule is best known as the reason behind ‘cookie’ banners, it is technology neutral and applies to...more
The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more
On December 18, 2023, the Federal Trade Commission (FTC) and Department of Justice Antitrust Division (DOJ) (together, the “agencies”) jointly released their final revised 2023 Merger Guidelines, reflecting modest adjustments...more
On December 18, 2023, the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) released the final 2023 Merger Guidelines (the Guidelines). While the final version of the Guidelines reflects...more
The US Federal Trade Commission (FTC) and US Department of Justice Antitrust Division (DOJ) issued their updated Merger Guidelines on December 18, 2023. These guidelines represent a significantly more...more
On December 18, 2023, the Federal Trade Commission (FTC) and the Antitrust Division of the Department of Justice (DOJ) (each an Agency, and collectively, the Agencies) released the final version of revised Merger Guidelines...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
On September 26, 2023, the U.S. Food & Drug Administration (FDA) added two new chapters to the agency’s draft guidance (the Draft Guidance): Chapter 11: Food Allergen Program and Chapter 16: Acidified Foods. These additions...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the CPPA has not officially started the formal...more
In July, the Federal Trade Commission (FTC) and Antitrust Division of the Department of Justice (DOJ) released a draft of proposed new merger guidelines, 18 months after FTC Chair Lina Khan and Assistant Attorney General...more
The California Privacy Protection Agency (CPPA) recently published two new sets of draft regulations addressing a range of cutting-edge data protection issues. Although the Agency has not officially started the formal...more
In July of 2023, the Connecticut Department of Energy and Environmental Protection (DEEP) released Draft Guidance through its Sustainable, Transparent, and Efficient Practices (STEPS) for Solar Development public engagement...more
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
On July 19, 2023, the Department of Justice Antitrust Division (DOJ) and Federal Trade Commission (FTC) (together, the Agencies) released a draft set of revised Merger Guidelines (the Revised Guidelines) to set forth the...more
On July 19, 2023, the Federal Trade Commission and Department of Justice jointly published long-anticipated proposed merger guidelines (the “Proposed Merger Guidelines”), which had been expected since President Biden issued...more
On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more
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
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