In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more
9/12/2023
/ Advertising ,
Compliance ,
Direct to Consumer Sales ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Labeling ,
Marketing ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Risk Factors
Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance,...more
Decentralized Clinical Trials (DCTs) are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s...more
On May 9, 2023, the U.S. Food and Drug Administration (FDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a joint statement regarding both agencies’ commitment to providing evidence-based...more
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more
5/16/2023
/ Algorithms ,
Cybersecurity ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Protection ,
Licensing Rules ,
Medical Devices ,
Popular ,
Reimbursements ,
Software ,
Technology Sector
On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19...more
On March 1, 2023, the Drug Enforcement Agency (DEA) officially published proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The DEA gave the public a 30...more
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA significantly changes the current regulatory...more
The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more
Many people experience hearing loss and related hearing issues. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing aid specialist in order to be properly diagnosed and fitted for a...more
On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker...more
Well into the third year of the global pandemic, with record inflation and the uncertain outcomes of geopolitical issues roiling global markets, the cannabis industry has nevertheless continued upon a similar path as recent...more
6/7/2022
/ Bankruptcy Court ,
Biden Administration ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
DEA ,
Department of Justice (DOJ) ,
Enforcement ,
Environmental Social & Governance (ESG) ,
Food and Drug Administration (FDA) ,
Infrastructure ,
Insolvency ,
NDAA ,
Patents ,
Securities and Exchange Commission (SEC) ,
State Labor Laws ,
Sustainability ,
Trademarks ,
USPTO ,
Veterans Administration
We invite you to enjoy a review of the food and beverage industry with bite size articles ranging from regulatory and real estate trends to litigation and M&A happenings.
The past two years have seen significant changes...more
6/2/2022
/ American Rescue Plan Act of 2021 ,
Beverage Manufacturers ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Investigations ,
Paycheck Protection Program (PPP) ,
Putative Class Actions ,
SBA ,
Whistleblowers
The fashion industry has certainly seen its fair share of change over the last year given consumer trends, geopolitical & public health issues, innovation in technology and legal developments and we don’t anticipate that...more
3/23/2022
/ Acquisitions ,
Blockchain ,
CASE Act ,
Copyright ,
Cosmetics ,
Cryptocurrency ,
Environmental Social & Governance (ESG) ,
Fashion Industry ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Financial Sponsors ,
Food and Drug Administration (FDA) ,
Investors ,
Mergers ,
Metaverse ,
Non-Fungible Tokens (NFTs) ,
Retailers ,
SCOTUS ,
Supply Chain ,
Sustainability ,
Trademark Infringement ,
Trademarks
The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key...more
On November 15, 2021, the U.S. Department of Health and Human Services (HHS) announced the withdrawal of the policy established during the previous administration that limited U.S. Food and Drug Administration’s (FDA) ability...more
Foley & Lardner’s Food & Beverage Industry Team has authored a new handbook entitled, “Food & Beverage Supply Chain Desk Reference.” For the sake of convenience, the Desk Reference includes quick answers to your legal needs...more
3/25/2021
/ Food and Drug Administration (FDA) ,
Food Recalls ,
Indemnification ,
License Agreements ,
Limitation of Liability Clause ,
Non-Disclosure Agreement ,
Product Recalls ,
Robinson-Patman Act ,
Sales & Distribution Agreements ,
Sellers ,
Sherman Act ,
Supply Chain ,
Terms and Conditions ,
The Clayton Act ,
Uniform Commercial Code (UCC) ,
USDA ,
Warranties
On the heels of a year beset by turmoil and the myriad challenges caused by the global pandemic, the cannabis industry nevertheless entered 2021 poised for significant growth amid a landscape teeming with opportunity. Public...more
2/26/2021
/ Banking Sector ,
Cannabidiol (CBD) oil ,
Cannabis-Related Businesses (CRBs) ,
Capital Markets ,
Controlled Substances Act ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Environmental Policies ,
Financial Institutions ,
Food and Drug Administration (FDA) ,
Insolvency ,
Insurance Industry ,
Internal Revenue Code (IRC) ,
Marijuana Related Businesses ,
Patent Litigation ,
Patents ,
Restructuring ,
Securities and Exchange Commission (SEC) ,
Trademarks ,
USPTO
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 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
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