-
2 months ago | 
jdsupra.com | Leo Caseria |Samantha Davis |Dominick DiSabatino
DTC Telehealth Platforms -
Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed legislation targeting promotional statements, specifically the Protecting Patients from Deceptive Drugs Ads Online Act (the “Act”), and fraud and abuse scrutiny from legislators.
-
Jan 14, 2025 | 
jdsupra.com | Dominick DiSabatino |Audrey Mercer
[co-author: Julian Klein*]On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft Guidance”).
-
Dec 10, 2024 | 
mondaq.com | Cheese Consumers |Dominick DiSabatino |Audrey Mercer
Earlier this week, the U.S. Food & Drug Administration
("FDA" or the "Agency") released its
long-anticipated final guidance
(the "Guidance") on predetermined change control plans
("PCCPs") for devices that utilize artificial
intelligence/machine learning ("AI/ML") software.
-
Dec 6, 2024 | 
jdsupra.com | Dominick DiSabatino |Audrey Mercer
Earlier this week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) released its long-anticipated final guidance (the “Guidance”) on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence/machine learning (“AI/ML”) software.
-
Dec 5, 2024 | 
natlawreview.com | Dominick DiSabatino
Earlier this week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) released its long-anticipated final guidance (the “Guidance”) on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence/machine learning (“AI/ML”) software.
-
Oct 30, 2024 | 
natlawreview.com | Dominick DiSabatino
Last month, the U.S. Department of Justice (“DOJ”) quietly updated its March 2023 guidance on the evaluation of corporate compliance programs.[i] Of course, DOJ did not conduct a major rewrite, but interestingly, the updated guidance emphasizes the impact, and evaluation, of emerging technologies on compliance as well as the importance of data when assessing compliance programs.
-
Sep 17, 2024 | 
natlawreview.com | Dominick DiSabatino
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.
-
Aug 14, 2024 | 
natlawreview.com | Dominick DiSabatino
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 communications made on its Healthcare Provider Branded Website for its accelerated approval drug, KRAZATI™ (adagrasib) tablets, for oral use (Krazati).[1] Krazati is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic...
-
Jul 31, 2024 | 
jdsupra.com | Dominick DiSabatino
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. (Kaleo) over social media promotion of AUVI-Q® (epinephrine injection, USP). The social content was posted on the personal Instagram account of Brittany Mahomes—yes, that Mahomes.
-
Jul 30, 2024 | 
natlawreview.com | Dominick DiSabatino
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. (Kaleo) over social media promotion of AUVI-Q® (epinephrine injection, USP). The social content was posted on the personal Instagram account of Brittany Mahomes—yes, that Mahomes.
