Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
In May 2025 the Department of Justice (DOJ) Criminal Division published its enforcement priorities, and the Civil Division has now followed suit with a memorandum of its own (the “Civil Division Memo”)...more
Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests...more
It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more
On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph...more
6/10/2020
/ Abbreviated New Drug Application (ANDA) ,
Administrative Orders ,
CARES Act ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare Reform ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rulemaking Process
On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import...more
On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. Four of the letters were issued to four companies that jointly manufacture and package...more
As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more
12/31/2018
/ 21st Century Cures Act ,
510(k) RTA ,
Biosimilars ,
CMMI ,
Comment Period ,
Cybersecurity ,
Digital Health ,
Draft Guidance ,
FDA De Novo Clearance ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Software Developers
This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more
6/22/2017
/ Amarin ,
Caronia ,
Commercial Speech ,
Criminal Convictions ,
FDAMA ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Misbranding ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Physicians ,
Prescribing Authority ,
Prescription Drugs ,
Public Health ,
Public Safety ,
Sorrell
In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more
As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more
4/14/2017
/ Amended Rules ,
Biologics ,
Enforcement Actions ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Hearing ,
Trump Administration
As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more