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
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
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
Todd Rundgren’s 1978 classic, “Can We Still Be Friends?” (arguably, his best song), came to mind when we saw that the Food and Drug Administration issued a draft guidance, “Formal Dispute Resolution and Administrative...more
Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes...more
MASSACHUSETTS - Massachusetts Federal Court Holds State Law Claims Alleging Misleading “Rapid Release” Labeling Of OTC Acetaminophen Tablets Preempted By Federal Food, Drug, And Cosmetic Act, As Tablets’ Dissolution Rate...more
Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
In June of this year, FDA announced a proposed rule that would permit approval for nonprescription drug products with an Additional Condition for Nonprescription Use—a category of nonprescription drugs where FDA determines...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of...more
In an unprecedented move, the U.S. Food and Drug Administration (FDA or Agency) sent a warning letter to Amazon.com, Inc. (Amazon), a fulfillment house, with respect to distributing over-the-counter (OTC) drug products that...more
Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles...more
More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”). The Food and Drug Administration (FDA) has...more
On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more
In last week's Federal Register, the U.S. Food and Drug Administration (FDA) updated and reissued the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2021. This Federal Register Notice announces...more
Enforcement by the Food and Drug Administration (FDA) against cannabidiol (CBD)-containing products continues through the issuance of two new warning letters. On March 22, 2021, FDA published a press release cautioning...more
This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a ...more
The U.S. Food and Drug Administration (FDA) issued Warning Letters this month to two companies concerning the marketing and sale of over-the-counter (OTC) drug products containing cannabidiol (CBD) as an inactive ingredient....more
Buried at page 415 of the Coronavirus Relief Bill is an Amendment to the Federal Food Drug and Cosmetic Act which Completely Changes How Over the Counter Drugs are Regulated by the FDA With few exceptions for drugs like...more