A new battle is emerging in the fight for health equity, and it’s centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter to the Food and Drug Administration (FDA) demanding that...more
The market for pet CBD has soared from almost zero in 2016 to roughly $60 million last year. By 2025, Nielsen Global Connect, a division of Nielsen that focuses on data for manufacturers and retailers, estimates that...more
In December 2020, then-US president Donald J. Trump signed into law the Holding Foreign Companies Accountable Act (the "HFCAA"). This law is just one measure, among many, that have been promulgated by legislative and...more
The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more
Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Connecticut AG Tong Doesn’t Want to Hear...more
Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Student Loan Servicer Agrees to Cancel $1.7...more
The National Association of Attorneys General sent a comment letter to the FDA, signed by a bipartisan group of 42 AGs, urging it to ensure that states’ authority to protect consumers is not preempted in its proposed rule...more
President Biden announced on January 10th that the Biden-Harris Administration is requiring insurance companies and group health plans to cover the cost of over-the-counter (OTC), at-home COVID-19 tests. Beginning January 15,...more
On September 28, 2021, companies trading in the United States over-the-counter securities markets (“OTC Markets”) that do not comply with amended Rule 15c-211 will no longer be eligible for quotation on the OTC Markets,...more
A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more
There’s a new class action trend consumer product companies need to be aware of that is not only causing additional stress when faced with a recall but also increased expense and adverse publicity. There are a number of...more
The Securities and Exchange Commission (SEC) has amended Rule 15c2-11 (the amended Rule), which governs the publication of quotations in the over-the-counter (OTC) markets, i.e., quotes that are published away from a...more
The changes will have implications for the growing secondary market for non-listed securities. On September 16, 2020, the US Securities and Exchange Commission (SEC) adopted amendments to Rule 15c2-11 (the amended Rule) of...more
On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more
The CARES Act adopts several measures to help stabilize the healthcare system, address health care issues directly and indirectly related to the current pandemic and ensure future preparedness. It also allocates $100 billion...more
As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph reform bill into law on March 27, 2020....more
FEDERAL NEWS - The big news this week was the FDA’s report to Congress on CBD. The report did not set out a timeline for usage guidelines, citing the need for more data. Commissioner Stephen Hahn did indicate he thought...more
As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight...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
Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical licence....more
Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top...more
Food/Dietary Supplements - FDA Releases Food Contact Guidance – The FDA published a guidance titled “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk:...more
18 April 2019 Almost one and a half years after the launch of the sector inquiry, the French Competition Authority ("FCA") has released its conclusions on the functioning of competition in the pharmaceutical sector....more
On March 5, the U.S. Food and Drug Administration (FDA) simultaneously published its independent testing results confirming the presence of asbestos in certain cosmetic products sold by Claire’s and by the girls'...more
On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more