As an emerging growth company in the healthy food & beverage (F&B) space, you might rightfully think, “My company is too young to consider either buying another company or selling to another company.” And depending on what...more
In the effort to enhance product quality and the integrity of the infant formula supply chain after contamination resulted in the 2022 baby formula shortage, Congress and the FDA took steps to ensure that infants and parents...more
In the world of healthy food and beverages, a crucial first step towards bringing a new product to the crowded U.S. market is identifying and understanding the regulatory authorities that oversee your product. This is not...more
11/30/2023
/ Advertising ,
Alcohol Beverage Control ,
Beverage Manufacturers ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Meat Inspection Act (FMIA) ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Organic ,
TTB ,
USDA
Intellectual property protection is essential for emerging companies in the healthy food and beverage (“F&B”) space to attract investors and stand out from competitors. To gain a competitive edge, companies should understand...more
On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more
After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more
10/11/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Emergency Use Authorization (EUA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
Proposed Rules ,
Shareholders
On October 6, 2023, the Drug Enforcement Administration (DEA) released a second temporary rule extending the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. This second extension, issued...more
If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create a transformative...more
9/15/2023
/ Artificial Intelligence ,
Change of Control ,
Collaboration ,
Contract Term ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Healthcare ,
Hospitals ,
License Renewals ,
Medical Devices ,
Pharmaceutical Industry ,
Pricing ,
Regulatory Requirements ,
Startups
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
At long last, the Drug Enforcement Administration (DEA) has signaled its consideration of a separate Special Registration for telemedicine prescribing for patients without requiring an in-person examination.
On August 4,...more
Agility and resiliency remain essential attributes for manufacturers in 2023. Manufacturers are no longer focused on figuring out when things will return to “normal.”
Instead, they are applying lessons learned from the...more
7/11/2023
/ Artificial Intelligence ,
Best Practices ,
Clawbacks ,
Compensation ,
Compliance ,
Customs and Border Protection ,
Cyber Threats ,
Cybersecurity ,
Enforcement ,
Environmental Protection Agency (EPA) ,
Final Rules ,
Intellectual Property Protection ,
Machine Learning ,
Manufacturers ,
Securities and Exchange Commission (SEC) ,
Supply Chain
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 May 10, 2023, the Drug Enforcement Agency (DEA) released a new regulation – “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – temporarily extending the “full set” of...more
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
The fashion industry has experienced another year of continued change driven by consumer trends, innovation in technology, geopolitical and public health issues, and legal developments, and we don’t anticipate that stopping...more
4/18/2023
/ Blockchain ,
Class Action ,
Copyright Infringement ,
Fashion Industry ,
Jack Daniels Properties Inc v VIP Products LLC ,
Lanham Act ,
Louis Vuitton ,
Mexico ,
Non-Fungible Tokens (NFTs) ,
Petition for Writ of Certiorari ,
PFAS ,
SCOTUS ,
Supply Chain ,
Trademarks
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
With Thanksgiving fast approaching, you have probably heard that there is a turkey shortage – brought about by a combination of rising costs for feed and fuel, continued labor shortages, and – if that were not enough –a...more
11/18/2022
/ Biden Administration ,
Compliance ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
Enforcement ,
Executive Orders ,
Labor Shortage ,
Poultry ,
Proposed Rules ,
Sherman Act ,
Supply Chain ,
Supply Shortages ,
Unfair or Deceptive Trade Practices ,
USDA
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