Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
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
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Update on Sesame Allergen Labeling - The U.S. Food and Drug Administration (FDA) has released an FDA Voices “Catching Up with Califf” update that addresses the...more
On June 27, 2023, the Food and Drug Administration (FDA) issued its final guidance for the presentation of “Quantitative Efficacy and Risk Information” in direct-to-consumer (DTC) promotional labeling and advertisements for...more
On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in...more
The wait is finally over. On June 7, 2023, after remaining silent for over an entire year, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first untitled letter of 2023 to...more
Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more
Businesses making health claims about their products (e.g., foods and dietary supplements) or services (e.g., apps) should take note of new guidance that the Federal Trade Commission (FTC) released at the end of December...more
Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more
On October 6, 2021, California Governor Gavin Newsom signed AB-45, creating an explicit framework for the manufacture and sale of hemp-derivative products in the state of California. While hemp was legalized at the federal...more
On May 19, 2021, Senators Rand Paul (R-KY), Ron Wyden (D-OR), and Jeff Merkley (D-OR) introduced The Hemp Access and Consumer Safety Act of 2021 (the “Act”), which generally provides a legal pathway for certain hemp-derived...more
Welcome to the latest edition of the Food & Beverage Digest, our roundup of court cases and regulations affecting the food, beverage, agribusiness, and cosmetics industries. This month, someone moved someone’s smoked...more
With the passing of the 2018 Farm Bill, the market for cannabis pet products has rapidly grown. As a result, broad-reaching marketing campaigns highlighting the available products and the claimed benefits have become much...more
If you are trying to navigate the space where hemp products intersects with animal products, it can be unclear as to which authority to turn to for guidance. In the United States, FDA, FTC, DEA and USDA share governance over...more
Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could...more
The Federal Trade Commission (“FTC”) has joined the U.S. Food and Drug Administration (“the “FDA”) in enforcing laws related to marketing CBD products. The FDA has historically issued warning letters and pursued companies...more
Join key industry stakeholders to discuss the latest developments affecting the dietary supplement industry. Now in a Virtual Format. American Conference Institute (ACI) together with the Council for Responsible Nutrition...more
FDA first raised the concept of Master Files for dietary supplements in its 2016 revised NDI Guidance. The agency views master files as a tool to promote better compliance with NDI notification requirements. Ingredient...more
The Federal Trade Commission (FTC), in its mission to protect consumers from deceptive and unfair commercial practices, has been particularly vigilant during the COVID-19 pandemic because of an expected increase in outright...more
Thursday, March 5th, the Food and Drug Administration (FDA) submitted a report to Congress providing an update on FDA action to develop an enforcement discretion policy and evaluate potential regulatory pathways for consumer...more
Dietary supplement manufacturers seeking to explain and market their products must carefully craft statements on supplement labels to ensure compliance with the Food and Drug Administration’s (“FDA’s”) regulations regarding...more
The U.S. Food and Drug Administration (FDA) sent a shot across the bow of the cannabidiol (CBD) industry on November 25. The FDA disclosed that it issued warning letters to 15 companies “for illegally selling products...more
ACI is delighted to present our inaugural Think Tank on Rx Drug Advertising and Promotion. Attend this intimate and in-depth symposium where the “who’s who” of pharmaceutical advertising and promotion will gather to discuss...more