The German Federal Court of Justice (Bundesgerichtshof), tasked with resolving a conflict between two competing pharmacists, sought guidance from the Court of Justice of the European Union ("CJEU") on interpreting the General...more
On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
This year, a laboratory issued a report wherein it claims to have tested over-the-counter and prescription acne products containing benzoyl peroxide and found what it deemed to be “unacceptably high” levels of benzene. In...more
On August 1, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Mirati Therapeutics Inc., a Bristol Myers Squibb Co. (Mirati), relating to promotional...more
On July 17, 2024—but just recently posted to the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) website—FDA issued its second untitled letter (letter) of the year to Kaleo, Inc....more
In December 2023, back when the ink was still drying on the amendments to Federal Rule of Evidence 702, the Southern District of New York excluded all five general causation experts proffered by plaintiffs in the In re...more
The vexing issue of whether insurance carriers, third-party administrators and self-insured employers will be required to pay for a broad array of non-prescription items (for example, over-the-counter medications, dietary...more
On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance to market the first over-the-counter (OTC) continuous glucose monitor (CGM). Dexcom’s Stelo Glucose Biosensor System (Stelo) is an integrated CGM...more
On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. ...more
On February 16, the U. S. District Court for the District of Oregon struck down the state’s drug price transparency law—The Prescription Drug Price Transparency Act (the “Act”)—ruling that the Act’s annual price increase...more
The Food and Drug Administration (FDA) regulates the marketing of dietary supplements, over-the-counter (OTC) drugs, cosmetics, medical devices, foods, infant formula, pet foods/supplements, and even e-cigarettes. However,...more
In a significant stride toward expanding access to addiction treatment services, the Substance Abuse and Mental Health Services Administration (SAMHSA) published, on January 31, its Final Rule allowing telehealth access to...more
On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation (Novartis)...more
Welcome to the latest issue of Bracewell’s FINRA Facts and Trends, a monthly newsletter devoted to condensing and digesting recent FINRA developments in the areas of enforcement, regulation and dispute resolution. We dedicate...more
In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and...more
From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
Tens of millions of Americans suffer from nasal and sinus congestion every year. People had come to rely on an increasing number of over-the-counter nasal decongestants to relieve their symptoms. The active ingredient in...more
At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more
This week, the Natural Products Association (NPA) filed a lawsuit against New York State challenging the constitutionality of a new state law prohibiting the sale of over-the-counter diet pills and dietary supplements for...more
A new law from New York State will require companies selling certain dietary supplements in the state to pay close attention to consumers' age. Last week, Governor Kathy Hochul signed into law Assembly Bill A5610D, which...more
It is well known that opioid overdoses have occurred at epidemic levels in the United States for years. According to the U.S. Centers for Disease Control and Prevention (CDC), opioid overdose deaths have increased from 21,089...more
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...more
The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are...more