13
Th5
What is Generally recognized as safe (GRAS)?
In food production, numerous ingredients are introduced to enhance flavors, preserve freshness, and improve appearance. While these additives offer diversity and convenience, questions arise about their safety. Generally Recognized As Safe (GRAS) designation ensures food safety by certifying substances as safe for consumption, either through scientific consensus or historical use. This article, GOL Solution delves […]
13
Th5
FDA Unified Registration and Listing System (FURLS)
In the realm of medical devices, adherence to regulations is non-negotiable. Enter the FDA Unified Registration and Listing System (FURLS), a pivotal tool that streamlines registration and listing procedures, fostering transparency and bolstering oversight for enhanced public health safety. As the FDA continues to refine its regulatory strategies, FURLS stands as a steadfast ally, embodying […]
13
Th5
What Is an Abbreviated New Drug Application (ANDA)?
ANDA (Abbreviated New Drug Applications) play a crucial role in ensuring the accessibility and affordability of healthcare. They serve as the gateway to market for generic drugs, providing consumers with more options at lower prices. In this article, GOL delves into the world of ANDAs, exploring their definition, application process, and important role in the […]
10
Th5
Cosmetics Direct: A New Era for FDA Cosmetic Registration – Elevate Your Cosmetics Brand
Cosmetics Direct: A New Era for FDA Cosmetic Registration – Elevate Your Cosmetics Brand December 18, 2023, marked a pivotal moment when the US Food and Drug Administration (FDA) unveiled the Cosmetics Direct online portal, opening doors for Vietnamese cosmetic companies to access the lucrative US market. In parallel, the FDA also released detailed guidelines […]
10
Th5
Free FEI Number Registration: Expedite your entry into the US market by acquiring your “key” to success.
FEI Number Registration plays a crucial role in exporting cosmetics to the United States market. Akin to a gateway key, this number is a mandatory requirement for businesses to register FDA cosmetics and list their products. This article delves into the details of FEI Number, encompassing its definition, significance, registration and lookup procedures, and the […]
09
Th5
Understanding risk assessment for food safety
Food safety risk assessment is a vital tool for protecting public health. It helps identify, assess, and control potential hazards in the food supply chain, preventing foodborne illnesses before they occur. As a result, ensuring food safety enhances quality and builds consumer trust. In this article, GOL will provide real-life examples of applying food safety […]
09
Th5
A Guide to Drug Master Files
Among the crucial steps towards FDA approval lies the creation of a Drug Master File (DMF), a comprehensive document that serves as a repository of vital information pertaining to a drug product. This detailed dossier encompasses intricate details about manufacturing facilities, production processes, active ingredients, packaging materials, and other critical aspects of the drug’s journey […]
27
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 […]
27
Th4
Explaining the Differences of the 3 FDA Medical Device Classes
Success in conquering the U.S. medical device market requires a clear understanding of the FDA classification system. In this article, GOL will provide you with knowledge about the differences of FDA medical device classes: Class I, Class II, and Class III, along with the regulatory requirements and market approval pathways for each type. What are […]
26
Th4
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 […]
