04
Th2
What is FDA Approval? Which products need FDA approval?
Amidst the growth in the healthcare and food industry, ensuring the safety and efficacy of products has become more crucial than ever. FDA approval, an integral part of this process, functions as a “quality assessment” by the United States Food and Drug Administration. In this article, GOL will delve into FDA approval and the products […]
04
Th2
FDA Regulations on Nutrition Facts Labels
Labeling food is one of the most important measures to protect consumer health. Through food labels, consumers can grasp information about the ingredients, nutritional content, quality, expiration date, and more of the product, enabling them to make choices suitable for their needs and health. This article will provide some basic information about the FDA’s regulations […]
04
Th2
What is UFI? Why is UFI necessary when registering with the FDA?
Do you know that food products, pharmaceuticals, and medical devices must be registered with the United States Food and Drug Administration (FDA) before being circulated in the market? One of the mandatory pieces of information to provide when registering with the FDA is the Unique Facility Identifier (UFI) code. So, what is the UFI code, […]
02
Th2
What is cGMP? Things consumers should know about cGMP
In the era of industrialization and modernization, the demand for cosmetic, pharmaceutical, and food products is continually rising. However, there are numerous low-quality products in the current market that do not guarantee the safety of consumers’ health. To address this issue, regulatory agencies have established standards for Good Manufacturing Practices (GMP), including cGMP. This is […]
02
Th2
What is FSVP? Overview of Foreign Supplier Verification Programs
When mentioning the United States Food and Drug Administration (FDA), people are often familiar with terms such as “FDA approved,” “FDA cleared,” “FDA 510k,” “PMA,” etc. In contrast, the Foreign Supplier Verification Programs (FSVP) are less known but play an extremely important role. In this article, GOL will provide detailed information about FSVP, specifically for […]
02
Th2
12 Frequently Asked Questions on FSMA regulations
The Food Safety Modernization Act (FSMA) is a U.S. law enacted in 2011 aimed at improving food safety throughout the food supply chain. FSMA is a complex law with many new regulations. Therefore, it’s not surprising that many people have questions about how to implement these regulations. Here are 12 frequently asked questions about FSMA. […]
02
Th2
The Overview of the Food Safety Modernization Act (FSMA)
In today’s context, food safety plays a crucial role in safeguarding consumer health and maintaining the industry’s reputation. To address the increasingly complex challenges of the global food system, the Food Safety Modernization Act (FSMA) has become a significant step for the United States government. Let’s explore in this article with GOL an overview of […]
21
Th1
Singapore’s export situation – potential for growth in the future
After the Covid-19 pandemic, it’s likely that the economies of all countries worldwide were significantly affected, and Singapore is probably no exception. So, let’s explore Singapore’s export situation and the potential for growth in the future with GOL in the article below! 1. Singapore’s export market In 2022, Singapore, a sovereign city-state and island nation […]
16
Th1
What is FDA 510(k)? Learn about the FDA 510(k) certification
The United States is one of the largest medical device markets globally. To be authorized to market medical devices in this industry, manufacturers must comply with the regulations of the Food and Drug Administration (FDA). One of the crucial regulations is the FDA 510(k) certification. So, what is FDA 510(k)? What are the regulations associated […]
16
Th1
What is a FDA medical device? Overview of Medical Device Classification
Medical devices are among the products that directly impact the health and well-being of users. Therefore, ensuring the quality and safety of medical devices is of utmost importance.In the United States, the Food and Drug Administration (FDA) is the authorized agency responsible for managing and overseeing the quality of medical devices. The FDA has established […]
