What You Need to Know: On December 18, 2020, the Food and Drug Administration issued the second emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Under...more
What You Need to Know: Late on December 11, 2020, the Food and Drug Administration issued the first emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 16 years of age and older....more
The Centers for Medicare & Medicaid Services (CMS) issued updated guidance on the thresholds that Applicable Manufacturers and Group Purchasing Organizations are required to report annually under the Sunshine Act (42 U.S.C. §...more
11/18/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Consumer Price Index ,
Covered Recipients ,
Data Collection ,
Department of Justice (DOJ) ,
Group Purchasing Organizations (GPO) ,
Manufacturers ,
Nurse Practitioners ,
Open Payments ,
Physicians ,
Social Security Act ,
Sunshine Act
The U.S. Food and Drug Administration (FDA) has continued to publish food safety updates relating to the coronavirus (COVID-19) pandemic throughout the pandemic. Foley’s Food and Beverage team have continued to monitor and...more
As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving. The FDA’s pivot is possibly a response to...more
The U.S. Food and Drug Administration (“FDA”) in March 2020 temporarily halted its domestic inspection program amid the coronavirus disease (COVID-19) pandemic. During this time, FDA continued to use other tools, including...more
The Financial Crimes Enforcement Network (“FinCEN”) recently released guidance for bank and financial institutions regarding the requirements and obligations for financial institutions under the Bank Secrecy Act (BSA) and...more
7/9/2020
/ Anti-Money Laundering ,
Bank Secrecy Act ,
Customer Due Diligence (CDD) ,
Due Diligence ,
Farm Bill ,
Financial Institutions ,
FinCEN ,
Guidance Update ,
Hemp Related Businesses ,
Interim Final Rules (IFR) ,
USDA
On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more
On Sunday, April 26th, the Centers for Disease Control and Prevention (CDC) and the Department of Labor (DOL) issued interim guidance specific to the meat and poultry processing industry to facilitate ongoing operations and...more
Last week, California Governor Gavin Newsom signed an Executive Order mandating 80 hours of supplemental paid sick leave for COVID-19 related reasons be provided to “food sector workers” at private companies with 500 or more...more
4/24/2020
/ California ,
Department of Industrial Relations ,
Employee Benefits ,
Employer Responsibilities ,
Executive Orders ,
Families First Coronavirus Response Act (FFCRA) ,
Food Service Workers ,
Food Supply ,
Full-Time Employees ,
Governor Newsom ,
Part-Time Employees ,
Posting Requirements ,
Sick Leave ,
State and Local Government
In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more
4/7/2020
/ 510(k) RTA ,
Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medical Devices ,
Medicare ,
Personal Protective Equipment ,
Prescription Drugs
Patients with COVID-19 may develop respiratory illness, distress, and insufficiency and may require respiratory devices including ventilators, anesthesia gas masks, and other devices to support their treatment. However, with...more
The spread of COVID-19 has led to questions for the food industry regarding the food supply chain, FDA’s role in protecting it, and changes to FDA operational procedures during the public health emergency. In response, FDA...more
3/20/2020
/ Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Homeland Security (DHS) ,
FEMA ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
FSMA ,
FSVP ,
Public Health ,
Public Health Emergency ,
Supply Chain ,
World Health Organization
...The coronavirus (provisionally named SARS-CoV-2, with its disease being named COVID-19) has been documented in six of the world’s seven continents (sparing only Antarctica), in more than 70 countries and territories. More...more
3/6/2020
/ Beverage Manufacturers ,
Business Continuity Plans ,
Business Interruption ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Force Majeure Clause ,
Imports ,
Infectious Diseases ,
Material Adverse Change Clauses (MACs) ,
OSHA ,
Performance Standards ,
Public Health ,
Risk Management ,
Suppliers ,
Supply Chain ,
Supply Contracts ,
World Health Organization
The USDA’s interim final rule on hemp provides needed clarity and certainty around its legal production. At the same time, producers must ensure they are not running afoul of state or tribal requirements. Foley & Lardner LLP...more
11/25/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Cannabis-Related Businesses (CRBs) ,
Controlled Substances Act ,
Farm Bill ,
Hemp ,
Hemp Cultivation ,
Interim Final Rules (IFR) ,
Interstate Commerce ,
Licensing Rules ,
Transportation Industry ,
Tribal Governments ,
USDA
On October 31, 2019 the U.S. Department of Agriculture (USDA) published an Interim Final Rule (84 FR 58522) establishing the U.S. Domestic Hemp Production Program and outlining a regulatory framework for monitoring hemp...more
11/1/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Comment Period ,
Controlled Substances ,
DEA ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Interim Final Rules (IFR) ,
Interstate Commerce ,
Licensing Rules ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Penalties ,
Public Comment ,
Regulatory Requirements ,
State and Local Government ,
Testing Requirements ,
Tribal Governments ,
USDA
Welcome to issue two of Foley’s Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue, we will explore collaboration between the...more
7/12/2019
/ Artificial Intelligence ,
Big Data ,
Biotechnology ,
Blockchain ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Machine Learning ,
Manufacturers ,
Regulatory Agenda ,
Supply Chain ,
USDA
In the face of an ever increasing global population set to surpass 9 billion by 2050, agriculture and science have converged to create sustainable, innovative solutions to food production. Cellular agriculture is perhaps the...more
6/19/2019
/ Agricultural Sector ,
Cattle ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Food Supply ,
Memorandum of Understanding ,
Poultry ,
Regulatory Agenda ,
Seafood ,
Technology ,
USDA
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS
On November 7, 2017, the Food and Drug Administration (FDA) released draft guidance regarding menu labeling requirements for certain chain restaurants and food establishments that are subject to the menu labeling requirements...more
In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more
9/12/2017
/ Administrative Procedure Act ,
Appeals ,
Chevron Deference ,
Commercial Marketing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First-to-File ,
Food and Drug Administration (FDA) ,
Marketing Exclusivity Periods ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Product Exclusivity ,
Reaffirmation ,
Summary Judgment
Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more
3/21/2017
/ 21st Century Cures Act ,
Draft Guidance ,
Enforcement Actions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Human Genes ,
Life Sciences ,
Medical Research ,
Public Comment ,
Public Health Service Act ,
Stem cells
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more
7/22/2016
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
CAFC ,
Commercial Marketing ,
Exclusivity ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Health Service Act ,
Rulemaking Process
The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more
2/12/2016
/ Advisory Committee ,
Amgen ,
Biologics ,
Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz
On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more