Do you want to make a breakthrough in the U.S. market with food, cosmetics, medical devices, and PPE. You will need to obtain U.S. FDA Certification first for these products, regulated by the government. This certificate safeguards public health by ensuring product safety. Since 1906, the FDA has protected consumers, impacting nearly 20% of global … Read more
Having US FDA Certification is crucial for medical device manufacturers to enter into the US market. Let’s learn how to get FDA Approval for Medical Devices in India through this article. Step 1: Understand the FDA Classification System Before getting FDA Approval, you must understand the FDA Classification system which is divided into three classes. … Read more
There is huge demand for food products and other items such as Drugs, Cosmetics, Colour Additives, Medical Devices, supplements, PPE Kits, etc. So, if you plan to export food products or any other such item to the USA, you must know about FDA compliance. Mandatory FDA Compliances for Exporting Products to USA 1. US FDA … Read more
The United States Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and efficacy of products available in the market. So, If you have received US FDA Certification or plan to get it, you must know about the process to verify US FDA Certification. Process to verify US FDA Certification The … Read more
In this article, you can find out the list of FDA “approved” and “not approved” products. What does FDA “Approved” mean? When the FDA grants approval to a drug, it signifies that CDER has thoroughly examined data regarding the drug’s effects. Furthermore, it concludes that the benefits it offers outweigh the known and potential risks … Read more
The manufacture of eye drops at the Chennai-based business has been halted by India’s Central Drugs Standard Control Organization (CDSCO) after the US FDA reportedly connected 55 adverse event instances to contaminated eye drops. Let’s read the latest updates for this news. US FDA suspends eye product production at Global Pharma site The Food and … Read more
It’s natural for us to think that everything FDA-cleared or authorised has undergone extensive testing, but that isn’t necessarily true. It is essential to be aware of the differences between US FDA Clearance vs US FDA Approval for Medical Devices. In this article, you will get to know about the US FDA Clearance vs US … Read more