Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
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
Food laws and regulations are evolving rapidly — you and your team must prepare now to navigate the changes and anticipate what’s next on the horizon. ACI's virtual Food Law and Regulation Boot Camp will equip you with the...more
In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more
FDA Releases Guidance for Voluntary Qualified Importer Program - The U.S. Food and Drug Administration (FDA) has released guidance with revisions to the Food Safety Modernization Act Voluntary Qualified Importer Program...more
On October 30, 2024, the U.S. Food and Drug Administration’s (FDA) newly minted Human Foods Program (HFP) published a list of priority deliverables for Fiscal Year 2025. By way of brief background, FDA designed the HFP to...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
The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will...more
The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more
The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more
The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more
On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Warns Company Selling CBD Oil - The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a...more
The U.S. Food and Drug Administration (FDA) has launched two new online dashboards that track key metrics reflecting the impacts from the FDA Food Safety Modernization Act (FSMA) regulations. The dashboards are part of...more
The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB) to help companies meet the requirements of the final rule “Mitigation Strategies...more
The Food and Drug Administration (FDA) recently announced it will hold a full-day public meeting on October 21, 2019, regarding “A New Era of Smarter Food Safety.” As explained in more detail in this memorandum, as part of...more
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the...more
The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more
The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive...more
The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more
The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more
The Office of Management and Budget (OMB) recently released the Fall 2018 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first...more
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA...more
The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration...more