The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
No Password Required: MITRE Engage Lead, Innovator in Cyber Deception, and Dance Community Builder
Georgia on My Mind: On the Frontlines of Federal Rulemaking With AG Carr — Regulatory Oversight Podcast
Podcast - Part 2: An FTC Official Speaks About the Regulation of AI Technology
Decoding Privacy Laws: Insights for Small to Mid-Sized Businesses — Regulatory Oversight Podcast
FCA Uncovered: Mitigating Risk in the Regulatory Spotlight — Regulatory Oversight Podcast
Proceso constituyente en Colombia Parte II
Navigating Facility Relocation: Legal and Practical Considerations — Regulatory Oversight Podcast
Leading With Purpose: Oregon AG Ellen Rosenblum Discusses Her Role at NAAG — Regulatory Oversight Podcast
The Standard Formula Podcast | Understanding the UK’s Matching Adjustment Regime
Food for Thought and Thoughts on Food: A Discussion on Scaling in Food and Other Industries
The Standard Formula Podcast | Solvency II Back to Basics: Third Country Branches and Cross-Border Provision of Services
Budding Regulations: Navigating the Cannabis Regulatory Landscape — Regulatory Oversight Podcast
A Conversation With NAAG Executive Director Brian Kane - Regulatory Oversight Podcast
Podcast - The CFPB's Proposal to Create a Public Registry
A Conversation With Judge Lawrence VanDyke of the US Court of Appeals for the Ninth Circuit - Regulatory Oversight Podcast
AI: Impact and Use in Background Screening - Crossover Episode With the Regulatory Oversight Podcast - FCRA Focus Podcast
AI: Impact and Use in Background Screening (Part Five) - Regulatory Oversight Podcast
AI: Impact and Use in the Financial Services Industry (Part Four) - Regulatory Oversight Podcast
AI: Impact and Use in the Health Care Industry (Part Three) - Regulatory Oversight Podcast
The US Food and Drug Administration’s (FDA) formal regulation of food packaging began in 1958 with the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. Since that time, the FDA has employed various...more
In a development that is expected to complicate many litigation challenges alleging that the presence of low levels of microplastics in food is inherently unsafe, officials from the US Food and Drug Administration (FDA or...more
Longtime efforts by the California Office of Environmental Health Hazard Assessment (OEHHA) to amend the so-called “short-form” safe harbor warnings for California’s Proposition 65 appear to be nearing completion. On 13 June...more
On this episode, Wiley's Amaru Sánchez is joined by Ryan Hawkins from Next Rung Technologies to discuss scaling across multiple industries and sectors and the difficulties startups are facing in the current investment...more
You have probably heard that scientists around the world are searching for sustainable, climate safe ways to keep up with the steadily increasing demand for protein sources to feed the World’s population. According to the...more
The U.S. Food and Drug Administration (FDA) has written a letter to the manufacturers and developers of new plant varieties, urging them to fully consider the potential ramifications of transferring the genes of allergens to...more
On March 4, 2021, we wrote about lawsuits concerning alleged high levels of heavy metals in baby foods (“Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers”). A precipitating factor was a staff report...more
A study published February 27, 2023, in the journal Nature Medicine has purportedly found possible links between erythritol and major adverse cardiovascular events such as heart attack or stroke. Erythritol is an artificial...more
U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf announced in a Jan. 31 statement that the agency intends to reorganize its Human Foods Program and Office of Regulatory Affairs (ORA) after receiving the...more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf on Jan. 31, 2023, announced a proposed restructuring of the agency's Human Foods Program in an effort to improve coordination among the FDA offices. These...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
On January 31, 2023, Commissioner Califf announced a new vision for the U.S. Food and Drug Administration (FDA)’s Human Foods Program. The Proposal calls for unifying the work currently done by the Center for Food Safety and...more
On January 31, 2023, the U.S. Food and Drug Administration (FDA) announced a proposal to restructure the agency’s human foods program. FDA regulates almost 80 percent of the nation’s food supply and this work is a cornerstone...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
LEGISLATION, REGULATIONS & STANDARDS - Omnibus Spending Bill Includes Congressional Notes to FDA - President Biden has signed a spending bill that includes additional funding for the U.S. Food and Drug Administration (FDA)...more
On December 6, 2022, the Reagan-Udall Foundation for the FDA (“RUF”) issued a highly anticipated report on FDA’s Human Foods Program (the Program) capturing the findings and recommendations of a months-long independent review...more
The U.S. Government Accountability Office (“GAO”) issued a July 2022 report to urging federal agencies to better coordinate regulatory guidance on food-related challenges, including diet-related chronic health conditions and...more
This week, the U.S. Food and Drug Administration (FDA) issued final guidance concerning regulatory oversight of food imported from Systems Recognition Arrangement (SRA) countries. FDA employs a Systems Recognition (SR)...more
Federal Made in U.S.A. Rule - In June 2021, the Federal Trade Commission (FTC) adopted its final rule for using “Made in U.S.A.” or any variation of that statement, including the U.S. flag. While this rule imposes no new...more
The U.S. Food and Drug Administration (FDA) recently released its Congressional Justification for the fiscal year (FY) 2023 budget. The agency is requesting $1.2 billion for its Foods Program to be allocated to initiatives...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) 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
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
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
For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...more