Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders....more
Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more
On August 6, the Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held a joint workshop to explore “Artificial Intelligence in Drug & Biological Product Development.”
The workshop...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
In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are classified as medical...more
In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory...more
The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not...more
An important new initiative focused on women’s health research – defined as “the study of health across a woman’s lifespan in order to preserve wellness and to prevent, diagnose, and treat disease” – was recently kicked off...more
A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...more
1/3/2024
/ Cosmetics ,
Food and Drug Administration (FDA) ,
GAO ,
Manufacturers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Product Labels ,
Regulatory Requirements ,
Reporting Requirements ,
Responsible Party ,
Risk Management ,
Serious Harm Standard
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
12/21/2023
/ Artificial Intelligence ,
Birth Control ,
Cannabidiol (CBD) oil ,
Digital Health ,
Drug & Alcohol Abuse ,
DSCSA ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Opioid ,
Over The Counter Drugs (OTC) ,
Proposed Rules ,
Reauthorization
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
It came as a surprise to nobody in health care circles when, on Friday, September 29, 2023, the Food and Drug Administration (FDA) publicly announced that its much-anticipated proposed rule on laboratory developed tests, or...more
A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this...more
As we previously reported, Perrigo Company’s subsidiary HRA Pharma submitted an application to the Food and Drug Administration (FDA) in the summer of 2022 to switch an existing prescription-only progestin birth control pill...more
The Federal Trade Commission’s (FTC) recent press release marks a continuation in government action against manufacturers of products infused with delta-8 tetrahydrocannabinol (delta-8). In May 2022, the U.S. Food and Drug...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
Since the late December 2022 seismic shift in the legal landscape for cosmetic companies – when Congress passed and President Biden signed the Modernization of Cosmetics Regulation Act, or MOCRA, into law (see our prior post...more
Regular readers of our Mintz Viewpoints will likely remember that the Consolidated Appropriations Act for 2023, signed into law by President Biden on December 29, 2022, included as one of its many titles the Food and Drug...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
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation...more
1/10/2023
/ Abbreviated New Drug Application (ANDA) ,
Animal Testing ,
Budgets ,
Clinical Trials ,
Consolidated Appropriations Act (CAA) ,
Cosmetics ,
Counterfeiting ,
Diversity and Inclusion Standards (D&I) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
New Amendments ,
Purple Book ,
User Fees
As the 2022 calendar year ended, the Consolidated Appropriations Act, 2023 was signed into law by President Biden. The massive piece of legislation included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA),...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
10/11/2022
/ 21st Century Cures Act ,
510(k) RTA ,
Biomedical Advanced Research and Development Authority (BARDA) ,
CDS ,
Coronavirus/COVID-19 ,
Dietary Guidelines ,
Draft Guidance ,
Emergency Use Authorization (EUA) ,
FDA De Novo Clearance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Over The Counter Drugs (OTC) ,
Proposed Rules ,
Public Health ,
Software ,
User Fees ,
Virus Testing
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...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
9/21/2022
/ Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Manufacturers ,
Medicare Part D ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Product Labels ,
Qui Tam ,
Self-Disclosure Requirements ,
Settlement