FDA Regulatory Insights & Compliance Guides

Structured Product Labeling: Ensuring FDA Compliance with fda labeling services

When you plan to export cosmetics, OTC drugs, pharmaceuticals, or food products to the United States, understanding FDA labeling requirements is critical. One of the most important aspects of compliance is Structured Product Labeling (SPL). This system ensures that your product information is submitted in a standardized, machine-readable format that the FDA can efficiently review and process. Navigating SPL requirements can be complex, but with the right knowledge and support

Jun 204 min read

MoCRA Cosmetic GMP Rule: Where It Stands in 2026 — and Why You Shouldn't Wait

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC MoCRA gave FDA the authority to establish, for the first time, federal Good Manufacturing Practice (GMP) requirements for cosmetics. Years in, that rule still isn't on the books — and the uncertainty is exactly why proactive manufacturers are building GMP-style systems now. What is the MoCRA cosmetic GMP requirement? Section 606 of the FD&C Act, as added by MoCRA, directs FDA

MOCRA

Jun 173 min read

FDA Approves Bemotrizinol (BEMT): What Sunscreen Brands Must Do to Sell in the U.S.

The FDA added bemotrizinol to the OTC sunscreen monograph. Here's the real timeline, the 18-month exclusivity catch, and the U.S. compliance steps brands need now.

OTC SUNSCREEN (BEMT)

Jun 154 min read

Navigating US FDA Registration with an FDA Registration Agent

Entering the US market with your cosmetic, OTC drug, pharmaceutical, or food product requires more than just compliance with product standards. One of the critical steps is registering your facility with the US Food and Drug Administration (FDA). For foreign companies, this process can be complex and requires a designated US-based representative known as an FDA registration agent. Understanding how to navigate FDA registration with an agent is essential to ensure your product

Jun 156 min read

Finding and How to Locate US FDA Agent for Your Needs

When you plan to export cosmetics, OTC drugs, pharmaceuticals, food, or personal care products to the United States, understanding FDA requirements is critical. One of the key regulatory obligations is appointing a U.S. Agent. This agent acts as your official liaison with the FDA, ensuring smooth communication and compliance with U.S. laws. Selecting the right FDA agent is not just a formality - it is a strategic decision that can impact your market entry and ongoing regulato

Jun 144 min read

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