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
In this blog, we have written a number of times on the topic of cultivated, i.e., lab grown meats. Last year, the FDA gave final regulatory approval for two different companies to sell their cultivated chicken in the United...more
LEGISLATION, REGULATIONS & STANDARDS - Group Petitions USDA to Prohibit ‘Low-Carbon Beef’ Label, Require Verification for Carbon Claims - The Environmental Working Group (EWG) has petitioned the U.S. Department of...more
The United States’ regulation of genetically engineered (GE) animals recently advanced with two new developments from the U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA). ...more
A California federal court has ordered the U.S. Food and Drug Administration (FDA) to conduct an assessment on the effects that could ensue if genetically engineered (GE) salmon escaped aquaculture farms and established...more
The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) has issued an instruction to field personnel, FSIS Notice 49-20, to begin implementing the agency’s new Adulterated Product Monitoring...more
On May 5, the First Circuit reversed a lower court’s dismissal of a putative class action brought against Conagra alleging violations of Massachusetts’s deceptive trade practices act. In reversing, it found that a company’s...more
The debate over the meaning of “100% Natural” remains unsettled. On May 7, 2020, the United States Court of Appeals for the First Circuit reversed a district court’s October 2017 decision to dismiss a consumer’s complaint...more
LEGISLATION, REGULATIONS & STANDARDS - EU Announces “Farm to Fork Strategy” The European Commission has announced the adoption of strategies to support biodiversity and “transition to a sustainable EU food system that...more
On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with EPA and the U.S. Department of Agriculture (USDA), launched a new initiative called “Feed Your Mind” to help consumers better understand...more
Consumers may not think of salmon as a drug, but according to a recent opinion out of the Northern District of California, certain genetically modified (GMO) salmon qualify as drugs under the Food, Drug, and Cosmetic Act...more
In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9,...more
LEGISLATION, REGULATIONS & STANDARDS - FTC Issues Warning Letters to CBD Companies - The U.S. Federal Trade Commission has announced that it sent warning letters to three companies selling “oils, tinctures, capsules,...more
LEGISLATION, REGULATIONS & STANDARDS - Bipartisan Bill Introduced to Standardize Food Date Labels - U.S. Reps. Chellie Pingree (D-Maine) and Dan Newhouse (R-Wash.) have introduced the Food Date Labeling Act, which aims...more
On June 11, 2019, President Trump signed an executive order directing the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and United States Department of Agriculture (USDA) to ease rules for...more
LEGISLATION, REGULATIONS & STANDARDS - Proposed Amendment Would Provide Funds for FDA Oversight of CBD - Rep. Jerry McNerney (D-Calif.), in partnership with the Natural Products Association, has reportedly filed an...more
FDA Holds Public Meeting on Cannabis - On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a widely anticipated public hearing with stakeholders on cannabis and cannabis-derived compounds to gain insights on...more
FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more
Food/Dietary Supplements - FDA Announces Plans to Strengthen Food Safety Program – The FDA proposed new funding under the 2020 budget to address multiple areas of the food safety system. ...more
20 years or five months? On March 8, 2019, nearly 20 years after AquaBounty Technology discovered a novel approach to increase the growth of Atlantic salmon, the U.S. Food and Drug Administration (FDA) finally “deactivated”...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Webinar on Genome Editing in Animals - The U.S. Food and Drug Administration has announced an April 25, 2019, public webinar about “genome editing in animals, an...more
Unlike a fine wine, a snack bar does not get better with age. Neither, apparently, does litigation. Last month, Judge William H. Pauley III in the Southern District of New York lifted a years-long stay in a lawsuit against...more
LEGISLATION, REGULATIONS & STANDARDS - CBD Banned from New York Restaurants, in Limbo in Idaho - New York City’s health department has reportedly ordered restaurants to stop serving products that contain cannabidiol...more
The USDA issued rules on December 20, 2018 requiring the disclosure of the presence of bioengineered foods and ingredients in food products, called the National Bioengineered Food Disclosure Standard (the Standard). The...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Releases GMO Labeling Standard - The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service has released the final National Bioengineered Food Disclosure...more
LEGISLATION, REGULATIONS & STANDARDS - USDA, FDA Announce Joint Regulation of Cell-Cultured Livestock and Poultry Products - The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have...more