Podcast: DeFi and Digital Assets: What do the UCC Amendments Mean for Business Transactions? [More with McGlinchey, Ep. 46]
Comment Deadline Approaching: Proposed Amendments Restricting Use of Prop 65 Short-Form Warnings
Hospices and The False Claims Act: Proposed Amendment Would Increase Liability Risk
New Developments in the World of Section 230
Videocast: Asset management regulation in 2020 videocast series – The SEC’s proposed accredited investor definition
Videocast: Asset management regulation in 2020 videocast series – Private fund regulatory developments
Proposed FRCP Changes: Effect on eDiscovery, RIM & IG (CLE)
Food laws and regulations are evolving rapidly — you and your team must prepare now to navigate the changes and anticipate what’s next on the horizon. ACI's virtual Food Law and Regulation Boot Camp will equip you with the...more
Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would...more
While the modalities of advertising may change, advertising’s core tenant of claims substantiation remains an unwavering constant. As such, legal and regulatory professionals in marketing and advertising set their calendars...more
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more
On November 1, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend Prior Notice requirements for imported human and animal food in two key ways: Additionally, on October 13, 2023, FDA...more
On March 15, 2022, the Senate Health, Education, Labor and Pensions Committee (HELP) held a full committee markup to offer several amendments and vote on S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New...more
When you go to the grocery store or farmer’s market and buy produce (I prefer the latter), do you consider how safe the produce is? If you are anything like me, perhaps you have wondered about the regulatory requirements...more
Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve requirements related to summary...more
The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more
The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more
On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional...more
The California Consumer Privacy Act of 2018 (“CCPA”) took effect on January 1, 2020. Days later on January 8, 2020, the California Senate Health Committee unanimously approved Senate bill A.B. 713 (the “Bill”) to establish...more
A little more than a week after California’s groundbreaking California Consumer Protection and Privacy Act (CCPA) went into effect on January 1, the Senate Health Committee unanimously approved A.B. 713, introduced by...more
LEGISLATION, REGULATIONS & STANDARDS - Proposed Amendment Would Provide Funds for FDA Oversight of CBD - Rep. Jerry McNerney (D-Calif.), in partnership with the Natural Products Association, has reportedly filed an...more
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more
The Canadian Federal government’s proposed amendments to the Cannabis Act and Regulations were published last month. Until February 20, 2019, Health Canada will be accepting comments on the proposed amendments, which set out...more
Earlier this month, the House of Representatives passed H.R. 2430: FDA Reauthorization Act of 2017 (FDARA) by voice vote. The FDARA seeks, among other things, to amend the Federal Food, Drug, and Cosmetic Act to revise and...more
After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more
DEPARTMENT OF LABOR - Procedures for Handling Retaliation Complaints - This rule establishes the final procedures and time frames for the handling of retaliation or whistleblower complaints under FDA Food Safety...more
In This Issue: Leading the News; Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more