FDA’s Updates on Dietary Supplement Regulation in 2025
The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Unlike pharmaceuticals, supplements do not require FDA approval before being marketed.
However, manufacturers are responsible for ensuring the safety of their products and accurate labeling.
In 2025, the FDA announced a major reorganization by establishing the Human Foods Program (HFP), aiming to modernize and strengthen the evaluation of food ingredients and dietary supplements.
Cosmetic Safety Dossier: Navigating Regulatory and International Convergence
Building a cosmetic safety dossier is no longer just a local requirement. With increasing alignment to international standards, ANVISA now demands a well-structured set of documents proving product and ingredient safety — especially for functional cosmetics. In this blog, we’ll show you how to create a robust dossier based on Brazilian regulations and global benchmarks such as ISO 16128, EU CosIng, and SCCS guidance.
COFEPRIS x FDA: What Are the Key Differences in Medical Device Regulatory Pathways?
Companies looking to commercialize medical devices internationally often target two major markets: the United States and Mexico. These countries are regulated by two robust authorities — the FDA (Food and Drug Administration) in the U.S. and COFEPRIS (Federal Commission for Protection against Sanitary Risks) in Mexico — each with distinct regulatory frameworks.
Understanding the differences between FDA and COFEPRIS approval processes is essential for planning efficient market entry, minimizing risks, and reducing time-to-market. In this blog post, we provide a clear comparison of both regulatory systems, including requirements, timelines, and strategic advantages.
PMDA Outlines Initiatives to Promote Pediatric Drug Development in Japan
PDMA’s report, published in Japanese in March and translated into English in April, outlines the need for action. The agency notes “growing concerns about the expansion of drug loss n Japan, where pharmaceuticals approved in the EU and the US are not being developed for Japanese patients.” The problem is particularly challenging for pediatric and orphan drugs, PMDA said.
Medical Device Registration at Cofepris: Everything You Need to Know in 2025
How to register medical devices with Cofepris in Mexico. This Blog explains risk classification, documentation, timelines, and tips for national and international companies.
Cosmetic or Grade 2: Understand the Categories and Avoid Rework
Before launching a cosmetic product in the Brazilian market, companies must identify whether it falls under Grade 1 or Grade 2 classification by Anvisa, Brazil’s health regulatory agency. This classification directly affects whether the product requires notification or full registration, which in turn impacts timelines, documentation, and compliance risks. In this Blog, we explain the difference between the two categories and how to ensure the correct classification to avoid costly rework.