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PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
Welcome to the Regulation Round Up, a regular bulletin highlighting the latest developments in UK and EU financial services regulation....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On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
Buchalter can assist by providing you with recommendations for testing laboratories, detailed analysis of state and federal PFAS regulations, create compliance programs tailored to meet regulatory requirements, assist in the...more
Last week, the United Kingdom's Financial Conduct Authority issued guidance on its proposed anti-greenwashing rule, which will come into effect at the end of May 2024. (Greenwashing is when a product, service, or firm is...more
The Federal Communications Commission has created a voluntary cybersecurity labeling program, also known as the “U.S. Cyber Trust Mark program,” for wireless consumer Internet of Things (IoT) products. The FCC is seeking...more
On 28 November 2023, the long-awaited UK regime for the labelling, marketing and disclosure of sustainable funds (Sustainability Disclosure Requirements or “SDR”) has been published in the Financial Conduct Authority’s...more
The Federal Communications Commission (FCC) has published its notice of proposed rulemaking (the NPRM) detailing the proposed creation of a voluntary cybersecurity labeling program for Internet of Things (IoT) or "smart"...more
On November 17, 2022, the FCC issued new broadband labeling rules that require Internet Service Providers (ISPs) to publish broadband “nutrition labels” in a standardized format informing customers of the pricing,...more
After some delay, the United Kingdom’s financial services regulator, the Financial Conduct Authority (the “FCA”) has published Consultation Paper CP 22/20 (Sustainability Disclosure Requirements (“SDR”) and investment labels)...more
A ban on the sale of nondurable food packaging in California containing PFAS chemicals goes into effect on January 1, 2023, which is now less than four months away. The ban was contained in Assembly Bill 1200, which was...more
Similar to the laws of several other states, the North Dakota law contains three main disclosure requirements that apply to “drug manufacturers” - The Governor of North Dakota signed House Bill 1032 into law on April 27,...more
On October 11, 2019, New York Governor Andrew M. Cuomo (D) signed legislation (S.2387-B/A.164-B) requiring menstrual product packages or boxes sold in New York State to contain a “plain and conspicuous printed list of all the...more
With the signature of Governor Andrew Cuomo last Friday, October 11 (not coincidentally also the United Nations’ “International Day of the Girl”), New York became the first state to require manufacturers of tampons and other...more
When Congress adopted legislation in 1958 requiring that manufacturers affix a label—today called a “Monroney sticker”—in the window of each new motor vehicle they produced showing the suggested retail price for the vehicle...more
Recently, the Federal Trade Commission (“FTC”) and the U.S. Food & Drug Administration (“FDA”) issued joint warning letters to four sellers of e-liquids, the nicotine “juice” used in vaping regarding their use of social media...more
On June 12, 2018, the US Food and Drug Administration (FDA) finalized its Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers guidance (Final Guidance)....more
Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4, the Agricultural Marketing Service (AMS) of the USDA proposed a rule...more
Ontario’s Ministry of Health and Long Term Care recently announced amendments to the regulations (Regulations) under the Healthy Menu Choices Act, 2015 (Act), which, among other things, add new categories of items exempt from...more
After years of deliberation and industry anticipation, China’s Ministry of Industry and Information Technology (“MIIT”) promulgated the “RoHS 2” regulation on January 21, 2016, with the formal (translated) title “Management...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Children's products, including toys, are regulated by the Consumer Product Safety Commission (CPSC) through the Consumer Product Safety Improvement Act of 2008 (CPSIA). Certain sections of CPSIA focus on children's toys....more