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
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
In a recently published Request for Information (RFI), the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) seeks public comment on options to potentially streamline and reduce the...more
On July 2, the US Department of Agriculture (USDA) Animal and Health Inspection Service (APHIS) published a Request for Information (RFI) seeking public comment on the improvement of regulatory processes governing genetically...more
Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more
Last week, the U.S. Department of Agriculture (USDA) issued grants of inspection to two companies, allowing them to begin producing and selling cell-cultivated chicken meat to consumers—a first in the U.S. This marks the end...more
The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) is advancing ahead in growing the regulatory landscape for developers and sponsors of animals with investigational intentional genomic...more
On March 7, 2022, the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) determined that Acceligen Inc.’s genome-edited, heat-tolerant cattle, pose a “low risk to humans, animals, the food...more
On March 7, 2022, the US Food and Drug Administration (FDA), operating under its New Animal Drug Authority, took a new, important regulatory step forward in assessing genome editing in animals. Specifically, the Agency...more
On March 7, 2022, the U.S. Food and Drug Administration (“FDA”) announced its “low-risk determination” to clear the marketing of food products derived from beef cattle that have been genetically altered to be more tolerant of...more
On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A...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
Innovations in genetic engineering have provided us with advancements in medicine, agriculture, food, and other applications. More recently, genetic engineering has been used to create the technology to combat COVID-19. While...more
At the outset of the Biden Administration it is clear that there will be a sharp pivot in the Federal Government’s approach to many environmental regulatory policies. One area that will be interesting to keep track 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
As the U.S. regulatory agencies responsible for oversight of agricultural biotechnology strive to evolve the regulatory framework applicable to such products, the U.S. Department of Agriculture (USDA) continues to lead the...more
AquaBounty Technologies’ path to the U.S. market for its genetically engineered (GE) salmon has been a long one. In 2015, the FDA approved AquaBounty’s application to create and farm its GE salmon (trade name, AquAdvantage)...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
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
In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued 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
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
LEGISLATION, REGULATIONS & STANDARDS - FDA Lifts Import Alert on GE Salmon - The U.S. Food and Drug Administration (FDA) has deactivated an import alert that prevented the introduction of genetically engineered (GE)...more
On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on...more
Proposition 65 - After California voters approved the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65), the state’s Office of Environmental Health Hazard Assessment (OEHHA) began publishing a list of...more
Lost among reports of the first locally transmitted cases of the Zika virus in the continental United States in late July (as well as concern over Zika transmission at the 2016 Summer Olympics in Rio de Janeiro, Brazil in...more