Medical Device Legal News with Sam Bernstein: Episode 11
2025 is set to be a busy year in UK consumer protection law. With the CMA issuing its annual plan for 2025 / 2026 on 27 March 2025 and its new powers to enforce consumer protection law under the Digital Markets, Competition...more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
This is the second in our 2025 Year in Preview series examining important trends in white collar law and investigations in the coming year. We will be posting further installments in the series throughout the next several...more
The ACCC sets out best marketing practices and companies’ obligations under the Australian Consumer Law, including strict penalties that may follow. In July 2023, the Australian Competition and Consumer Commission (ACCC)...more
Antitrust enforcers remained active across the globe, with the announcement by the FTC and DOJ of proposed guidelines that have an emphasis on tech mergers in the United States, and several investigations of major tech deals...more
On the heels of the historic proposed changes to the Hart‑Scott‑Rodino (“HSR”) merger review process, the U.S. Department of Justice Antitrust Division and the Federal Trade Commission released the 2023 Draft Merger...more
First released in 2000 and updated in 2013, the FTC’s .com Disclosures guidance has been relied on by advertisers hoping to “make effective disclosures in digital advertising” for the last two decades. The FTC’s Leslie Fair...more
On April 13, 2020, the Department of Justice’s Antitrust Division and the Federal Trade Commission’s Bureau of Competition released a joint statement and press release regarding “competition in labor markets” and potential...more
Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018, the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020....more
On Friday, the Federal Trade Commission (“FTC”) and the Antitrust Division of the U.S. Department of Justice (“DOJ”) released joint draft Vertical Merger Guidelines (“Guidelines”) for public comment. This much anticipated...more
On January 10, 2020 the United States Department of Justice (DOJ) and the Federal Trade Commission (FTC) released draft guidelines outlining the agencies' "analytical techniques, practices, and enforcement policy" for...more
In this month's edition of our Privacy & Cybersecurity Update, we take a look at guidance on artificial intelligence released by the U.K. Information Commissioner's Office and the Turing Institute, as well as guidance...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
Companies regulated by the Environmental Protection Agency (EPA) have long complained that EPA too often uses guidance documents improperly, both to expand regulatory requirements beyond what the law permits and to avoid...more
FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more
Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more