Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...more
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more
On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either a “drug” or a “device,” FDA does not...more
The Ensuring Innovation Act recently became law after passing in the Senate with unanimous, bipartisan support. According to one Senator, the intent of the legislation was to “close loopholes to prevent awarding market...more
The United States Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA), two of the U.S. Federal agencies responsible for regulation of agricultural biotech recently announced two comment periods...more
The US Environmental Protection Agency has proposed to amend its pesticide regulations to exempt from FIFRA, the federal pesticide statute, certain pesticidal substances (PIPs) created in plants using biotechnology, so long...more
Key Takeaways - What Happened: EPA proposed to exempt certain biotechnology-derived plant-incorporated protectants (PIPs) from FIFRA registration and FFDCA tolerance requirements....more
A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For...more
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices - Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG - The wearable device market is emerging as a key player...more
On September 25, 2018, the U.S. House of Representatives passed without objection the Pandemic and All-Hazards Preparedness And Advancing Innovation Act of 2018. Introduced on July 16, 2018, by Congresswoman Susan W. Brooks...more
The next wave of emerging agricultural biotechnology is set for its first regulatory showdown. Cell-cultured meat (“CCM”) allows your steak to be grown in a lab by replicating animal cells. Some CCM products are even created...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a...more
On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of the AquAdvantage Salmon, a genetically modified Atlantic salmon. In...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Exela Pharma Sciences, LLC v. EKR Therapeutics, LLC et al. - 5:13-cv-00111; filed August 8, 2013 in the Western...more
In This Issue: - Can Experts Testify as to the Ethics or State of Mind of Corporate Defendants? - Patent Reform for Biotech Companies - United States v. Caronia and its Implications for Off-Label...more