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
On November 7, 2013, the Food and Drug Administration (FDA) announced that it has tentatively determined that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) for any use in food. PHOs are...more
In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices....more
In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more
On Friday, January 4, 2013, FDA announced the pre-publication of two long-awaited proposed rules implementing parts of the Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011....more