Posts by Marc Sanchez
FDA Regulatory Assessments in Fundraising
Explore how regulatory assessment influences funding for medical devices, ensuring compliance and investor confidence in healthcare innovations.
Read MoreThe Potential Impacts of AI on FDA Regulation
As AI technologies continue to advance, the FDA is adapting its regulatory frameworks to ensure the safety and efficacy of AI-integrated products on the market.
Read MoreUnderstanding the FDA’s Proposed Rule on Food Labeling
The FDA’s proposed Front-of-Package Nutrition Labeling Rule marks a key step in improving transparency for consumers. Learn more about it in this blog!
Read MoreWhy FDA Staff Losses Are a Public Health Concern
The recent wave of staff reductions at the U.S. Food and Drug Administration (FDA) has raised urgent questions about the Agency’s ability to fulfill its critical mission. The FDA is more than just another government entity—it is the backbone of the nation’s public health infrastructure, responsible for ensuring the safety of $2.6 trillion in consumption…
Read MoreThe Ultimate Guide to FDA Registration: Types, Renewals, and Guidelines
Navigating the complexities of FDA registrations is essential for companies. Here, we will showcase the ultimate guide to the types of FDA registration.
Read MoreThe Role and Importance of a US Agent for FDA Registration
Need a US agent for FDA registration? Get expert legal support for FDA compliance, food facility registration, and more. Contact us today for assistance!
Read MoreCan Elon Musk Use DOGE to Dismantle the FDA?
As the new Presidential administration takes shape, much of the attention has been on Elon Musk. Using an Executive Order, the President established the Department of Government Efficiency to implement the President’s DOGE Agenda. It appears Mr. Musk’s appointment wasn’t subject to confirmation by the U.S. Senate. As discussed below, this may limit the actions…
Read MoreFDA Greenlights ZYN: Harm Reduction & PMTA Pathway
On January 16, 2025, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway. This marks the first instance of the FDA authorizing nicotine pouches, which are smokeless, tobacco-free products designed to deliver nicotine when placed between the gum and lip.…
Read More2023 Recall Trends & Projections: Year-End Recap | FDA Atty
As 2024 concludes, it’s time to reflect on the key trends that defined the year in product recalls and consider how 2024 is shaping up. In particular, how it compared to 2023. Businesses and consumers alike have faced a rapidly evolving regulatory landscape, and staying informed about recall patterns is crucial for compliance and risk…
Read MoreFDA Influencer Marketing Guide for Compliance
Navigating the complex landscape of FDA advertising guidelines is crucial for food and drug companies looking to leverage the power of influencer marketing while staying within legal boundaries. This comprehensive guide outlines essential regulations and best practices to help you maintain compliance and build effective marketing strategies. FDA Regulations for Influencer Marketing in the Food…
Read MoreSupreme Court Flavored Vape Case: Key Takeaways
The U.S. Supreme Court heard oral arguments on Monday in Wages and White Lion Investments. The Court heard arguments regarding the FDA’s defense of refusing to let two e-cigarette companies sell nicotine-containing flavored vape products deemed risky to youths. The FDA appealed a lower court’s decision, claiming it failed to follow proper legal procedures under…
Read MoreNicotine Pouches and FDA Regulations
Nicotine pouches have gained popularity as an alternative to smoking. Here, we will guide you through the FDA regulations surrounding nicotine pouches.
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