Tag: What are the 5 categories of FDA?
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Form FDA 3500A and Cosmetic Adverse Event Reporting: Regulatory Reporting Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) fundamentally changed how cosmetic safety issues must be reported in the United States. Cosmetic companies are now legally required to report serious adverse events associated with their products to the US FDA within defined timelines. One of the primary tools used to fulfill this obligation is Form FDA…
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US Drug Registration: FDA Drug Registration and Listing Guide
US Drug Registration is a mandatory regulatory requirement for any company involved in manufacturing, processing, repacking, relabeling, or distributing drugs intended for the United States market. This process is governed by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Both US-based and foreign pharmaceutical companies must…
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US Drug Registration: Complete Guide to FDA Drug Registration and Listing
Entering the United States pharmaceutical market requires strict regulatory compliance. One of the most critical steps is US Drug Registration, a mandatory process governed by the U.S. Food and Drug Administration (FDA). Whether you are a domestic manufacturer, foreign drug company, repacker, relabeler, or private label distributor, FDA drug registration and listing is not optional—it…
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US FDA/USP Substance Registration System (SRS): Complete Guide
The FDA/USP Substance Registration System (SRS) is a critical regulatory framework used in the United States to uniquely identify and standardize information about substances found in FDA-regulated products. Whether you manufacture pharmaceuticals, biologics, excipients, or combination products, understanding SRS is essential for compliant submissions and smooth regulatory interactions. What Is the FDA/USP Substance Registration System…
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US FDA Drug Registration and Listing Database: A Practical Guide for Manufacturers
The US FDA Drug Registration and Listing Database is a critical compliance tool for any company involved in manufacturing, processing, packing, or distributing drugs intended for the United States market. Whether you are a pharmaceutical manufacturer based in India or a global exporter supplying the US, understanding how this database works is essential for regulatory…
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FDA US Agent for Drugs: Complete Guide for Global Manufacturers
For pharmaceutical companies located outside the United States, appointing an FDA US Agent for drugs is not optional—it is a mandatory regulatory requirement. The US FDA requires every foreign drug manufacturer, repacker, relabeler, and exporter to designate a US-based agent who acts as the official communication bridge between the company and the U.S. Food and…
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US FDA Certificate: Complete Global Guide to FDA Certification, Verification, Cost & Registration
By XPRO America – Global US FDA Consultancy & Compliance Partner Entering the United States market is a major growth milestone for any manufacturer or exporter. Whether you deal in food, pharmaceuticals, medical devices, cosmetics, dietary supplements, or APIs, one requirement stands above the rest: US FDA compliance. Yet, confusion around the term US FDA…