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
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more
On January 4, 2023, the Biden Administration belatedly released the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions (the Unified Agenda). Typically published twice a year in the spring and the fall by the...more
The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) recently published an advanced notice of proposed rulemaking (ANPR) seeking public comment pertaining to the labeling of meat and...more
On September 3, 2021, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) published an Advance Notice of Proposed Rulemaking (ANPR) on the Labeling of Meat or Poultry Products...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
On June 11, 2021, the U.S. Food and Drug Administration (FDA) withdrew an advanced notice of proposed rulemaking (ANPRM) for premium cigars issued in March 2018 as part of the Spring 2021 Unified Agenda of Regulatory and...more
In seeking public comments and suggestions on how to improve the exemption process for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the US Environmental Protection Agency (EPA or Agency)...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
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more
Outlook for This Week in the Nation's Capital - Senate Floor. The Senate is schedule to finish its work this evening on the minibus appropriations bill, a three-bill spending package that includes Energy and Water...more
Earlier today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., announced FDA’s issuance of an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower...more
On July 28, 2017, the U.S. Food and Drug Administration (FDA or the Agency) announced a new, comprehensive plan for tobacco and nicotine regulation that will place nicotine, and the issue of addiction, at the center of the...more
On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more
FDA publishes an advance notice of proposed rulemaking for products containing liquid nicotine. On July 1, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking (ANPRM) to obtain...more