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
2024 is poised to be a big year for food regulation, particularly as federal agencies work to implement their regulatory agendas in preparation for a possible change in administration after the 2024 election. Here are the key...more
The U.S. Food and Drug Administration (FDA) recently announced the results of its pilot program evaluating whether several third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls...more
The White House Office of Management and Budget (OMB) recently released the Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions, which outlines the rulemaking actions currently under development by each federal...more
We’re a few weeks into 2023, and while some new year’s resolutions may have already fallen to the wayside, there are plenty of food law issues that will take us through 2023 and beyond. Here are key issues the Hogan Lovells...more
The Office of Management and Budget (OMB) recently released the Fall 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
On November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its Final Rule: Requirements for Additional Traceability Records for Certain Foods (“Final Rule”) in the Federal Register. The Final Rule...more
FDA published a final rule “Requirements for Additional Traceability Records for Certain Foods” designed to improve the agency's ability to rapidly track and trace food through the supply chain. The final rule maintains the...more
On November 7, 2022, the U.S. Food and Drug Administration ("FDA") sent the Food Safety Modernization Act ("FSMA") Final Rule on Requirements for Additional Traceability Records for Certain Foods to the Office of the Federal...more
The United States Food and Drug Administration (FDA) recently announced two developments on inspection-related activities providing insight into FDA’s perspective on the legal obligations that apply to food facilities, and...more
The Office of Management and Budget (OMB) recently released the Spring 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
The U.S. Food and Drug Administration (FDA) recently released an updated list of priority draft and final guidance documents related to foods and dietary supplements that the agency intends to publish by the end of this year....more
Politico has published a report on the U.S. Food and Drug Administration (FDA) based on more than 50 interviews with current and former employees of the agency, including former FDA commissioners. “There is a remarkable level...more
FDA recently issued guidance announcing its intent to exercise enforcement discretion for several specific provisions in the agency’s regulations implementing the FDA Food Safety Modernization Act (FSMA). The guidance is...more
The U.S. Food and Drug Administration (FDA) has issued guidance indicating that it will not enforce particular provisions implementing the Food Safety Modernization Act (FSMA). “In certain situations the FDA has determined it...more
When you go to the grocery store or farmer’s market and buy produce (I prefer the latter), do you consider how safe the produce is? If you are anything like me, perhaps you have wondered about the regulatory requirements...more
The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of priority draft and final guidance documents...more
The Office of Management and Budget (OMB) recently released the Fall 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
The U.S. Food and Drug Administration (FDA) recently issued a final rule regarding Laboratory Accreditation for Analyses of Foods (LAAF). This memorandum summarizes the regulation. The U.S. Food and Drug Administration...more
Warning Letter Provides Insight on FDA’s Priorities - The U.S. Food and Drug Administration’s (FDA) Warning Letter to Maribel’s Sweets, Inc., provides an important look into how FDA is implementing the Food Safety...more
The U.S. Food and Drug Administration (FDA) recently hosted a three-day virtual summit on e-commerce, which focused on food safety for foods ordered online and delivered directly to consumers. Because of the increasing...more
The U.S. Food and Drug Administration (FDA) announced this week that it is partnering with Stop Foodborne Illness to co-host a webinar series entitled “Collaborating on Culture in the New Era of Smarter Food Safety.” The...more
FDA recently entered into domestic mutual reliance (DMR) agreements with the states of California, Florida, Utah, and Wisconsin to help ensure the safety of domestic food production and distribution systems. FDA’s goal is to...more
Shook Of Counsel John Johnson III will join AIB International’s Judi Lazaro for the second webinar in a series on answering frequently asked questions about the U.S. Food and Drug Administration. During the webinar, Johnson...more
The U.S. Food and Drug Administration (FDA) recently issued a review of work done over the last year in advancing its New Era of Smarter Food Safety (New Era) Blueprint, which was released in July 2020. In a corresponding FDA...more
The U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) recently released a list of priority draft and final guidance documents that the...more