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
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: •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
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
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
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
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
On February 26, 2019, the FDA published yet another additional proposed rule in the proceedings to finalize the OTC Sunscreen Monograph. Comments on the proposed rule may be filed with the FDA within 90 days from the...more
The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC)...more
The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen...more
Recent developments in Congress deserve the attention of companies with over-the-counter drug products. Major legislation addressing comprehensive reform of the OTC drug monograph process, which nearly passed last year, has...more
In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter...more
Newly approved tariffs would impose 10 to eventual 25% tariffs on hundreds of chemical ingredients imported from China used for many FDA-regulated products, including dietary supplements, OTC drugs, and cosmetics....more
For the 26.9 million sufferers of sinus pain and pressure, nasal sprays are one of the most recommended and effective methods of relief. But one product, labeled as a CVS brand nasal mist, is being pulled off the shelves....more