On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more
10/3/2023
/ CLIA ,
Draft Guidance ,
Emergency Use Authorization (EUA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Jurisdiction ,
Laboratory Developed Tests ,
Litigation Strategies ,
Medical Devices ,
Proposed Rules ,
Public Comment ,
Reporting Requirements ,
Warning Letters
Effective upon Publication, USDA’s Interim Final Rule Sets Forth One Important Part of the Regime for Marketing Hemp Products in the United States -
This week, the U.S. Department of Agriculture (USDA) issued an interim...more
11/1/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Comment Period ,
Controlled Substances ,
DEA ,
Food and Drug Administration (FDA) ,
Hemp ,
Interim Final Rules (IFR) ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Marketing ,
Public Comment ,
Regulatory Requirements ,
State and Local Government ,
Tribal Governments ,
USDA
On April 2, 2019, the U.S. Food and Drug Administration (“FDA” or “Agency”) proposed a new regulatory framework to address the development and marketing of artificial intelligence and machine learning-based software as a...more
4/10/2019
/ Algorithms ,
Artificial Intelligence ,
Comment Period ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
Medical Devices ,
Popular ,
Public Comment ,
Regulatory Agenda ,
Software
Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds -
On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more
4/8/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Enforcement ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Marijuana ,
Marijuana Related Businesses ,
Public Comment ,
Public Health ,
Public Meetings ,
Public Notice ,
Regulatory Agenda ,
Regulatory Authority ,
Warning Letters
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more
1/23/2019
/ Comment Period ,
Cybersecurity ,
Digital Health ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Mobile Medical Applications ,
Popular ,
PreCert Pilot Program ,
Precertification ,
Public Comment ,
Software ,
Telemedicine