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
This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....more
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more
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 non-public letter sent earlier last week, the US Department of Health and Human Services (HHS) recommended to the US Drug Enforcement Administration (DEA) that marijuana be re-classified under the Controlled Substances...more
With the memorandum of understanding between the Food and Drug Administration (FDA) and the Association of Animal Feed Control Officials (AAFCO) set to expire, the FDA is proposing an alternative path to market for the...more
The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more
The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in...more
The U.S. Food and Drug Administration (FDA) is facing pressure from Congress and the medical community to enhance its oversight of online prescription drug advertising. The pressure comes amidst growing concerns about social...more
Artificial intelligence and machine learning are transforming the medical device industry. Simultaneously, companies are working to gain Food and Drug Administration approval and obtain intellectual property protection for...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
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
Laboratories in the United States are facing a major regulatory landscape shift. The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory...more
“Hi, we’re with the Bureau of Alcohol, Tobacco and Firearms, and we’d like to take a look at your tobacco product sales invoices, shipping records, and PACT Act reports.”...more
In a much-anticipated move, sources recently reported that the Drug Enforcement Administration (“DEA”) will recommend rescheduling cannabis from a Schedule I substance to a Schedule III substance under the federal Controlled...more
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are...more
On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more
On April 29, 2024, after years of false starts trying to expand oversight of laboratory developed tests (“LDTs”) through administrative and legislative actions, FDA announced the much-anticipated—and highly...more
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage the risks of cannabidiol...more
Supporters of hemp-derived cannabidiol (CBD) who hoped the Food and Drug Administration would adopt a more progressive view of CBD were disappointed when FDA Chief Robert Califf recently testified that FDA does not consider...more
Originally published in Healthcare Michigan, Volume 41, No. 4 - The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary...more
For music aficionados, many would agree that the rock band, Pink Floyd, was ahead of its time. “Welcome to the Machine,” from the 1975 album Wish You Were Here, was one of those transformative songs for one of this Bulletin’s...more
Our Food & Beverage Team reports good news for the industry: product labels can follow either the Food and Drug Administration’s current version or any new version of a rule defining “healthy.”...more