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What is biosimilar medicine? FDA Review and Approval Process
Biologically similar drugs are increasingly attracting attention in the healthcare industry. As a novel and promising type of medication, they hold the potential to bring numerous benefits to patients, healthcare providers, and the overall healthcare system. In this article, let’s delve deeper with GOL into what biological similar drugs are and what the FDA Evaluation […]
04
Th3
FDA approved vs FDA cleared: The differences you need to know
Are you confused about the FDA Approved vs FDA Cleared? These two terms are commonly used when discussing medical products, food, and cosmetics in the United States. However, many people misunderstand their actual meanings. The following article of GOL will help clarify the difference between “FDA Approved” and “FDA Cleared”. Understanding these two terms will […]
04
Th3
What is Premarket Approval (PMA)? – The difference between FDA (510k) and PMA
When launching a new medical device to the market, manufacturers must comply with the strict regulations of the U.S. Food and Drug Administration (FDA). The two most common processes are PMA (Premarket Approval) and 510(k). In this article, GOL will explain what PMA is, compare it to 510(k), and help you understand the appropriate process […]
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MoCRA and new FDA regulations for cosmetics
Since being signed into law in December 2022, the Modernization of Cosmetics Regulations Act (MoCRA) has brought about significant changes to the cosmetics industry in the United States. MoCRA introduces a new legal framework, focusing on enhancing safety and transparency for consumers. In this article, let’s explore with GOL the impacts of MoCRA on cosmetics […]
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Are FSVP food importers required to register with the FDA?
Food safety is a top concern for consumers, regulators, and food importers worldwide. In the United States, the Food and Drug Administration (FDA) plays a crucial role in ensuring the safety of the food supply. One of FDA’s important programs is the Foreign Supplier Verification Program (FSVP), designed to ensure that imported foods into the […]
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Selling Online to the US – An E-commerce superpower
In an era of profound digitalization, online business has become an indispensable part of the global economy. And among the powerhouses in this field, the United States stands out with its role as a dominant force in the e-commerce market. With its large population, robust economy, and developed consumer culture, the US is not only […]
28
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FDA Import Holds and Detentions
The U.S. market is an important export market for many Vietnamese businesses, especially in the food, pharmaceutical, and cosmetic sectors. However, to export products to this market, businesses need to comply with numerous strict regulations from the U.S. Food and Drug Administration (FDA). FDA Import Holds and Detentions is one of the crucial regulations that […]
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What importers need to know about FSVP regulations for Food Safety
Imported food plays a crucial role in the global food supply system. However, ensuring food safety poses a significant challenge for importers. Food safety regulations are becoming increasingly complex, and compliance with these regulations is necessary to protect consumers and your business. The Foreign Supplier Verification Program (FSVP) by the United States Food and Drug […]
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The FDA Drug Approval Process: Ensuring Safety and Efficacy of Medications
Health and consumer safety are always top priorities for every nation. In the field of healthcare, ensuring the quality and effectiveness of medications plays an incredibly important role. The U.S. Food and Drug Administration (FDA) takes the lead in fulfilling this mission through a rigorous and meticulous drug approval process. This article will delve into […]
04
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what are the benefits of Quality Management System (QMS) in an organization
In the increasingly competitive business environment, the quality of products/services is a crucial factor determining the success of a company. The Quality Management System (QMS) is an effective tool that helps businesses enhance the quality of their products/services, meet customer requirements, and strengthen competitiveness. To delve deeper into what QMS is and the benefits it […]
