The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more
The Centers for Disease Control and Prevention (CDC) reports that as of Jan. 8, 2021, about 6.7 million people have received at least one dose of a COVID-19 vaccine, far short of the prediction by the Trump Administration of...more
1/12/2021
/ Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Response ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Moderna Inc. ,
National Institute of Health (NIH) ,
Operation Warp Speed ,
Pfizer ,
Public Health Emergency ,
State and Local Government ,
Vaccinations
Since March 2020, and in some cases before, the U.S. government, Congress and external entities have worked to design plans to reduce the impact of COVID-19 and ultimately prepare for the development and distribution of a...more
A presidential race called by media outlets for former Vice President Joe Biden, coupled with a diminished Democratic majority in the U.S. House of Representatives and a narrowly divided Senate, translates into a federal...more
11/12/2020
/ Affordable Care Act ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Judicial Appointments ,
Legislative Agendas ,
Presidential Elections ,
Public Policy ,
Regulatory Agenda
A hemp trade association and a hemp company have filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit challenging the U.S. Drug Enforcement Administration's (DEA) Interim Final Rule (IFR). The...more
The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its...more
The U.S. Department of Agriculture (USDA) has officially requested additional comments on its Hemp Interim Final Rule (IFR). USDA's request, made on Sept. 8, 2020, follows ongoing industry feedback concerning a list of IFR...more
In struggling to address the evolving COVID-19 pandemic, the United States and many other countries continue to face major shortages of Personal Protective Equipment (PPE), such as N95 masks, gowns and other vital materials...more
8/3/2020
/ Bank Secrecy Act ,
Coronavirus/COVID-19 ,
Customs and Border Protection ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FinCEN ,
Fraud ,
Imports ,
Medical Devices ,
Medical Supplies ,
Personal Protective Equipment ,
Price Gouging ,
Scams ,
Supply Chain
Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more
In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more
The COVID-19 crisis has revealed the extent to which the United States and other countries are dependent upon a well-functioning global supply chain of critical medical supplies, including ventilators and Personal Protective...more
The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many...more
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
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
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