On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell...more
On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments."...more
At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to...more
On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in...more
The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation (QSR; 21 CFR Part 820)...more
In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and...more
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...more
On Tuesday, December 14, 2021, the U.S. Food and Drug Administration (FDA) hosted a webinar discussing the final rule, Medical Device De Novo Classification Process, and associated guidance document updates. The final rule,...more
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published...more
The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in response to the virus. Under the traditional U.S. Food and Drug Administration...more
ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain...more
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others...more
5/12/2021
/ ACIP ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Contamination ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
Moderna Inc. ,
Pfizer ,
Vaccinations
In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration’s (FDA) recently...more
The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.:
(1) Engaged in “fraud-on-the-FDA” when obtaining...more
By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS...more
On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device...more
4/12/2021
/ Coronavirus/COVID-19 ,
Data Transfers ,
EU ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Medical Directives ,
Popular ,
Software
In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”)...more
During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more
3/31/2021
/ Biden Administration ,
CARES Act ,
Collaboration ,
Coronavirus/COVID-19 ,
Defense Contracts ,
Defense Production Act ,
Department of Justice (DOJ) ,
EU ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
Life Sciences ,
Merck ,
Pharmaceutical Industry ,
Popular ,
Private Sector ,
Public Health Emergency ,
Supply Chain ,
Trump Administration ,
Vaccinations ,
World Health Organization
U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more
3/4/2021
/ Algorithms ,
Artificial Intelligence ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Machine Learning ,
Manufacturers ,
Medical Devices ,
Popular ,
Regulatory Oversight ,
Software Developers
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In...more
While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly,...more
On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying...more
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year....more
Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of...more