On June 12, 2025, Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged in...more
6/24/2025
/ Advertising ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Marketing ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Proposed Rules ,
Telemedicine
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more
4/3/2025
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Medical Devices ,
Regulatory Authority ,
Regulatory Requirements ,
Vacated
On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more
3/13/2025
/ Appeals ,
Drug Compounding ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Pharmacies ,
Preliminary Injunctions ,
Prescription Drugs ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more
1/8/2025
/ Compliance ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Labeling ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
On December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide, Mazdutide, Survodutide, and...more
Brand companies who own GLP-1 products have been pushing the Food and Drug Administration (FDA) to limit their compounding. On August 28, 2024, Eli Lilly and Company submitted a nomination to request that its GLP-1 product,...more
On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved”. The tirzepatide injection had appeared...more
On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024....more
After formulating an exciting new healthy food or beverage, the packaging it comes in may feel like an afterthought. It should not be. Food packaging has become an increasingly hot topic among federal and state regulators,...more
3/15/2024
/ Beverage Manufacturers ,
Code of Federal Regulations (CFR) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
GRAS ,
Green Guides ,
PFAS ,
Product Packaging ,
Recycling ,
Sustainability
Whether formulating a new food or developing a novel ingredient, a critical first step is understanding the regulatory framework for bringing a new ingredient (or a food containing a new ingredient) to the market. This...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
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 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
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
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
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