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
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
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 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
In a signal to industry that the period for education and enforcement discretion related to the Foreign Supplier Verification Programs (FSVP) may be concluding, the Food and Drug Administration (FDA) recently issued its first...more
The Food Safety Modernization Act (“FSMA”) ushered in a sea change in the government’s regulation of food safety. Pursuant to FSMA, the FDA has promulgated a series of rules, including a 2015 rule related to the Foreign...more
Top News - FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions - On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more
In Spring 2016, the FDA released its long-awaited Final Rule on Sanitary Transportation of Human and Animal Food (the “Rule”). The regulation, which constitutes one of seven final rules implementing the Food Safety and...more
The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency...more
On April 6, 2016, the Food and Drug Administration (FDA) published its Final Rule on the Sanitary Transportation of Human and Animal Food (the Final Rule). These long-awaited regulations were mandated by the Food Safety...more
In an effort to prevent wide-scale public harm through the nation’s food supply from acts of terrorism, the U.S. Food and Drug Administration (FDA) has published its final rule regarding Mitigation Strategies to Protect Food...more
No more sugar coating—the Rules impose new label requirements, and manufacturers will incur additional costs. The US Food and Drug Administration (FDA or the Agency) has announced the issuance of two new final rules: one...more
FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration. The rule will require domestic and foreign food facilities...more
The Rule is broad in scope and reaches nearly every party involved in the shipment of food through the United States. On April 6, the Food and Drug Administration (FDA) published its final rule governing the sanitary...more
DEPARTMENT OF LABOR - Procedures for Handling Retaliation Complaints - This rule establishes the final procedures and time frames for the handling of retaliation or whistleblower complaints under FDA Food Safety...more
The U.S. Food and Drug Administration (FDA) has published its final rule regarding the Sanitary Transportation of Human and Animal Food (“Sanitary Transport Rule”). Applicable to shippers, loaders, receivers, and carriers of...more
TSCA/FIFRA/IRIS/NTP/TRI - EPA Extends Comment Period On Chlorinated Paraffins Risk Assessments: On February 22, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft risk...more
FDA Approves First Genetically Modified Food-Producing Animal - On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of...more
On November 27, 2015, the Food and Drug Administration (FDA) published the final rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals under the FDA Food Safety Modernization Act...more
Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the...more
Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more
Twenty-five years after Congress first tried to ensure that garbage trucks aren’t also used to haul fresh produce, a federal regulation establishing sanitation standards for the transportation of human and animal food by...more
EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more