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Th4
FDA regulations on color additives used in the US
Color additives play a crucial role in capturing consumer attention and making food, pharmaceuticals, cosmetics, and medical devices more appealing. However, the use of color additives in these products must adhere to strict regulations set forth by the United States Food and Drug Administration (FDA) to ensure consumer safety. In this article, GOL will provide […]
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What is FDA QSR? Differences between FDA QSR and ISO 13485
In the realm of medical device manufacturing, compliance with regulatory standards is paramount. Two key frameworks governing quality management are the Food and Drug Administration Quality System Regulation (FDA QSR) and the International Organization for Standardization (ISO) 13485. While both aim to ensure product safety and quality, they differ in scope, certification processes, and global […]
26
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What is FDA 483? Important Details About FDA 483 Forms
The FDA 483 form plays a crucial role in safeguarding consumer health by ensuring that products manufactured and circulated in the US market meet strict quality and safety standards. In this article, GOL will provide you with important information about the FDA 483 form, including its contents, issuance process, response methods, and consequences of non-compliance. […]
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How to renew FDA registration? Details on time and cost
Understanding the ins and outs of renewing FDA registration can be daunting for businesses in regulated industries like food, drugs, and medical devices, given the strict deadlines, regulatory requirements, and potential fees involved, all of which are essential for maintaining compliance and ensuring operational continuity. In this article, GOL will delve into the intricacies of […]
28
Th3
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 […]
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 […]
28
Th2
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 […]
04
Th2
What are dietary supplements? FDA regulations on dietary supplements
Dietary supplements serve not only as a supplementary source of nutrients but also constitute a field that attracts the interest of many individuals seeking ways to maintain and enhance their health. However, to ensure that dietary supplements meet strict safety and quality standards, the United States Food and Drug Administration (FDA) has imposed rigorous regulations. […]
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
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, […]
