The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as...more
The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more
In the midst of expanded development and marketing of products containing cannabis and cannabis-derived compounds, President Donald Trump's FY 2021 proposed budget includes an additional $5 million for the U.S. Food and Drug...more
2/12/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Congressional Committees ,
Dietary Supplements ,
Enforcement Programs ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Hemp ,
Information Reports ,
Marijuana-Infused Edibles ,
Regulatory Agenda ,
Trump Administration
On November 25, 2019, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to several companies for illegally selling products containing cannabidiol (CBD). The FDA also published a revised...more
The U.S. Department of Agriculture (USDA) has issued an Interim Final Rule (IFR) for the establishment of a domestic hemp production program. By publishing the rule in the form of an IFR, USDA is able to issue guidance before...more
Wage and Hour -
80/20 Rule Still Followed in Some Parts -
The U.S. Department of Labor (DOL) issued guidance doing away with the so-called "80/20 rule" in November 2018. District courts have greeted the new guidance...more
7/11/2019
/ Americans with Disabilities Act (ADA) ,
Auer Deference ,
Beverage Manufacturers ,
Cannabidiol (CBD) oil ,
Class Action ,
Department of Labor (DOL) ,
Dietary Supplements ,
Duty to Defend ,
Employer Liability Issues ,
Fair Labor Standards Act (FLSA) ,
FBI ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
GrubHub ,
Hiring & Firing ,
Liquor Control Acts ,
New Guidance ,
Price-Fixing ,
Putative Class Actions ,
Securities Litigation ,
Wage and Hour ,
Wine & Alcohol
On June 14, 2019, the FDA published a Consumer Update entitled "What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD."
In the Update,...more
6/19/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Food and Drug Administration (FDA) ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Marijuana-Infused Edibles ,
Medical Marijuana ,
Public Health ,
Regulatory Agenda ,
Request For Information
• With the dramatic expansion of CBD products in the market, the U.S. Food and Drug Administration (FDA) is reviewing whether its current regulatory framework is appropriate, and if not, what modifications are needed.
• The...more
6/7/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Hemp ,
Labeling ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Public Hearing ,
Regulatory Oversight
On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more
4/2/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Marketing ,
Food Safety ,
Health and Safety ,
Hemp ,
Manufacturers ,
Marijuana ,
Marijuana-Infused Edibles ,
Product Labels ,
Public Hearing ,
Regulatory Oversight
FDA has announced plans to seek congressional and stakeholder input on "possible alternative approaches" to regulating cannabis and cannabis-derived products. The announcement came as Commissioner Scott Gottlieb spoke on the...more
3/4/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Enforcement ,
Food and Drug Administration (FDA) ,
Food Safety ,
Hemp ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Agenda ,
Regulatory Oversight
CMS Regulation -
CMS and ONC Unveil Proposals Transforming Interoperability and Patient Access to Data -
The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health...more
3/1/2019
/ 21st Century Cures Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Electronic Health Record Incentives ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
ONC ,
Opioid ,
Proposed Rules
The federal government shutdown ended Friday, Jan. 25, 2019, with the enactment of a Continuing Resolution to fund government agencies at approximately FY19 levels through Feb. 15. That means federal employees are headed back...more
On Jan. 15, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene...more
Note -
On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more
1/25/2019
/ Abbreviated New Drug Application (ANDA) ,
Agricultural Sector ,
Appropriations Bill ,
Continuing Resolution ,
Department of Health and Human Services (HHS) ,
Drug Approvals ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Medical Devices ,
Popular
With the enactment of the Agriculture Improvement Act of 2018 (Farm Bill) on Dec. 20, 2018, hemp and cannabis derivatives with extremely low concentrations of Tetrahydrocannabinol (THC)—less than 0.3 percent on a dry weight...more
1/4/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Controlled Substances Act ,
Decriminalization of Marijuana ,
Dietary Supplements ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Oversight
Regulation -
FDA-USDA Propose Joint Regulatory Framework for Cell-Grown Meat -
On Nov. 16, 2018, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) issued a joint statement...more
12/24/2018
/ Americans with Disabilities Act (ADA) ,
Appeals ,
Beverage Manufacturers ,
Biotechnology ,
Brand ,
Breweries ,
Class Action ,
Comment Period ,
Consent Agreements ,
Constitutional Challenges ,
Copyright ,
Dismissals ,
Dormant Commerce Clause ,
Due Process ,
Equal Protection ,
EU ,
False Advertising ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Intellectual Property Litigation ,
Interstate Commerce ,
Joint Statements ,
Local Ordinance ,
Misrepresentation ,
New Legislation ,
NLEA ,
Preemption ,
Public Comment ,
Putative Class Actions ,
Regulatory Oversight ,
Remand ,
Restaurant Industry ,
Reversal ,
Summary Judgment ,
Trademark Registration ,
Trademarks ,
USDA ,
Vacated ,
Website Accessibility
The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more
Regulation -
OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor -
On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more
12/20/2018
/ Advisory Opinions ,
Americans with Disabilities Act (ADA) ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
EPSDT ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medical Devices ,
Medicare Advantage ,
Notice of Proposed Rulemaking (NOPR) ,
OIG ,
Protected Class ,
Remuneration ,
Safe Harbors ,
Screening Procedures ,
Telemedicine ,
Unfair or Deceptive Trade Practices
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
12/17/2018
/ Clinical Laboratories ,
Data Integrity ,
Dietary Supplements ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Stem cells