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
In the latest episode of Health Law Diagnosed, host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead.
Hear from a dynamic group of...more
The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding...more
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more
11/10/2023
/ Cosmetics ,
Disclosure Requirements ,
Drug Compounding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Costs ,
Manufacturers ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Reporting Requirements ,
Trademarks
U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their...more
On March 9, 2023, the Food and Drug Administration (FDA) published a final rule that updates the Mammography Quality Standards Act (MQSA) to reflect advances in mammography technology and, among other requirements,...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
7/21/2022
/ Birth Control ,
Dobbs v. Jackson Women’s Health Organization ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Roe v Wade ,
SCOTUS
In our most recent year-end blog post on devices and diagnostic products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020 with respect to laboratory developed tests (LDTs) and clinical...more
Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more
1/29/2021
/ Biden Administration ,
CARES Act ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Orange Book ,
PDUFA ,
Pharmaceutical Industry ,
Public Health Service Act ,
Regulatory Agenda
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
11/6/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Laboratory Developed Tests ,
Life Sciences ,
Over The Counter Drugs (OTC) ,
Virus Testing
The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating...more
10/7/2020
/ Coronavirus/COVID-19 ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Intended Use ,
OPDP ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules
About a month ago, I predicted on this blog that Food and Drug Administration’s November 2020 enforcement discretion deadline announced as part of its Comprehensive Regenerative Medicine Policy Framework would most likely not...more
Since our last roundup-style blog post on the response of the Food and Drug Administration (FDA) to the COVID-19 public health emergency, the agency has taken a wide variety of additional actions with the goal of getting...more
Over the past month or so, our Health Care Team has published a number of posts examining important developments and trends in health law and policy during 2019, as well as providing some thoughts on what we expect to see in...more
1/27/2020
/ Anti-Kickback Statute ,
Biologics ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Healthcare Reform ,
OCR ,
Pharmaceutical Industry ,
Stark Law
Times, They Are A-Changin’ -
On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more
9/2/2016
/ Amarin ,
Animal Drugs ,
Biologics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Health Care Providers ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Preliminary Injunctions ,
Prescription Drugs ,
Public Hearing ,
Public Safety ,
Settlement
As our regular readers know, we’ve been tracking regulatory approvals, reimbursement policies, pharmacy substitution laws, and other developments related to biosimilar biological products. Biosimilars rely on the safety and...more