Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision support (“CDS”) software and general wellness products provide clearer, more...more
2/5/2026
/ Digital Health ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Healthcare ,
Medical Devices ,
Medical Software ,
Mobile Health Apps ,
New Guidance ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency ,
Wearable Technology
Key Takeaways - FDA evaluates direct-to-consumer ads based on the overall impression conveyed to consumers. Visuals, graphics, and on-screen text can equally contribute to an ad’s message. SUPERs function only as secondary...more
Key Takeaways - FDA oversight of AI mental health tools is accelerating. The Digital Health Advisory Committee’s (“DHAC’s”) November 2025 meeting highlights FDA’s increased attention to digital health technologies such as...more
As Sam Cooke famously sang, “It’s been a long, a long time coming.” In the latest sign that the Food and Drug Administration is maintaining its focus on direct-to-consumer (“DTC”) advertising, the Office of Prescription Drug...more
12/8/2025
/ Advertising ,
Direct to Consumer Sales ,
Enforcement Actions ,
False Advertising ,
Food and Drug Administration (FDA) ,
Marketing ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
“Let it grow, let it blossom,” said Eric Clapton, and so the Food and Drug Administration expects of expanded access programs with the issuance of its guidance on “Expanded Access to Investigational Drugs for Treatment Use:...more
In this episode, AGG Life Sciences co-chair Alan Minsk and Healthcare partner Andrew Tsui examine how the Centers for Medicare & Medicaid Services ("CMS") may apply the Medicare Conditions of Participation ("COPs") to...more
In this episode, AGG Life Sciences co-chair Alan Minsk is joined by AGG Healthcare and Life Sciences partner David Blank, former Senior Counsel at the HHS Office of Inspector General (“OIG”), for an in-depth discussion on...more
A recent Food and Drug Administration Warning Letter offers a timely reminder that how a digital health product is promoted can be just as consequential as how it functions. An August 2025 Warning Letter, issued after an FDA...more
In this episode, AGG Life Sciences co-chairs Alan Minsk and Gabe Scannapieco unpack recent developments at the U.S. Department of Justice that could reshape regulatory risk for life sciences organizations.
They discuss the...more
Channeling Tracy Chapman’s 1988 hit, the Food and Drug Administration and the Department of Health & Human Services (“HHS”) are “talkin’ bout a revolution” in drug promotion. While many have described the latest actions as...more
Chuck Berry’s 1959 hit, “Back in the U.S.A.” came to mind as we reviewed the Food and Drug Administration’s recent move to bolster the resilience of the U.S. pharmaceutical supply chain by introducing the FDA PreCheck...more
In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former acting general counsel and principal deputy general counsel of the U.S....more
8/15/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Kickbacks ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Rulemaking Process ,
SCOTUS ,
Trump v CASA
The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more
Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more
AGG partner and Life Science team member, Allison Raley, will present a complimentary webinar examining how life sciences companies can overcome challenges in the face of U.S. tariffs. As international trade tensions persist...more
6/5/2025
/ Best Practices ,
Biologics ,
Continuing Legal Education ,
Country of Origin ,
Distributors ,
Exclusions ,
Imports ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Risk Assessment ,
Risk Mitigation ,
Supply Chain ,
Tariff Classifications ,
Tariffs ,
Trade Relations ,
US Trade Policies ,
Webinars
Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more
In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more
5/23/2025
/ Compliance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Imports ,
Inspection Rights ,
International Trade ,
Life Sciences ,
Manufacturers ,
New Regulations ,
Regulatory Requirements
In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...more
When the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a recent Notice of Violation (“NOV”), some of us were humming, “Let’s get clinical,” to the tune of Olivia Newton-John’s 1982 hit...more
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
3/26/2025
/ Compliance ,
Draft Guidance ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Public Health ,
Regulatory Requirements ,
Risk Management ,
Warning Letters
This (bad) pun of the 1974 Carly Simon song, “Haven’t Got Time for the Pain,” came to mind when we read the Food and Drug Administration’s Office of Prescription Drug Promotion’s (“OPDP”) first Notice of Violation of 2025....more
As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, less attention has been given to the new administration’s regulatory impact abroad....more
In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, the Food and Drug Administration began offering pharmaceutical companies their own...more
While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal to allow photographs...more
In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International Initiative, is joined by Alan Minsk, AGG Food & Drug chair, to unpack the intricacies of working with the Food and Drug...more