Quick Guide to Administrative Hearings
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Solicitors General Insights: A Deep Dive With Mississippi and Tennessee Solicitors General — Regulatory Oversight Podcast
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[Webinar] Growing Greener: Navigating Environmental Laws in the Cannabis Industry
From FDA to USDA – the Alphabet Soup of Regulatory Agencies and How the Government Has Permitted Some Flexibility During the Pandemic
Employment Law This Week®: Recalibrating Federal Agencies, Marijuana Legalization, the Changing Nature of Work - Monthly Rundown
Polsinelli Podcasts: Cloud Computing, From Cybersecurity to Confidentiality Issues
On August 11, 2025, the U.S. Drug Enforcement Administration officially transmitted a request to the Department of Health and Human Services to loosen the federal restriction on psilocybin, seeking to move one of the...more
Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured,...more
On July 25, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) published a joint Request for Information (RFI) to solicit information and data to help the agencies develop a...more
On July 23, 2025, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) announced a joint Request for Information (RFI) to gather information and data to help establish a federally recognized...more
On July 23, the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) announced a coordinated initiative to address health risks associated with so-called “ultra-processed foods.”...more
The U.S. Food and Drug Administration (FDA) announced on July 14, 2025, that it is extending the public comment period on its proposed method for ranking chemicals in the food supply by 30 days, to August 18, 2025. As...more
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more
On June 3, 2025, lawmakers introduced the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act in the U.S. House of Representatives, aiming to bring U.S. sunscreen regulations in line with scientific...more
The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking chemicals in the food supply. According to the document, the systematic post-market assessment of food...more
Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same....more
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
When the Make America Healthy Again (MAHA) Commission unveiled its Make Our Children Healthy Again Assessment on May 22 (reissued May 28), it framed the document as a clarion call: U.S. regulators must combat childhood...more
We won’t bury the lede. The short but surprising answer here is yes. And this may be a rule ripe for reconsideration by the National Advertising Division (NAD)....more
The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a plan to phase out all petroleum-based synthetic dyes from the nation’s food supply. The plan is...more
In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...more
On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last...more
Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more
On April 22, 2025, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration announced a series of new measures to quickly phase out all petroleum-based synthetic dyes from the nation’s food...more
In FDA v. Wages and White Lion Investments LLC, the U.S. Supreme Court’s unanimous decision in favor of the Food and Drug Administration serves as a reminder of the deference still accorded to regulatory agencies post-Loper...more
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
The regulatory environment is top of mind these days coupled with speculation over potential change. Any attention paid to our obligations for safe and lawful operation is positive as we strive for compliance by our companies...more