28
Mar
How to get FDA approval? Tips for a Successful Application
The phrase “FDA Approved” frequently appears on product labels, particularly for items promoted online. But are these products genuinely approved by the FDA? The FDA only grants approval to a product following a thorough assessment of its safety and efficacy. The majority of products are not mandated to obtain FDA approval before being marketed in […]
28
Mar
Why is food safety important to the Food Business?
Food safety is the foundation for the success of any food business. It not only helps protect consumer health but also brings numerous other benefits to businesses such as enhancing brand reputation, increasing revenue, and minimizing risks. In the following article, let’s discuss in detail the importance of food safety for food businesses with GOL, […]
04
Mar
Ways to Obtain and Search FDA Food Facility Registration Number
Registering your food facility with the U.S. Food and Drug Administration (FDA) is mandatory for all facilities that manufacture, process, pack, or hold food (for both humans and animals) and dietary supplements for consumption in the United States. This registration helps the FDA track and trace food in case of a food safety incident. This […]
04
Mar
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
Mar
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
Mar
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 […]
29
Feb
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 […]
29
Feb
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 […]
29
Feb
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
Feb
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 […]
