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US FDA NDC Code Registration

US FDA NDC Code Registration Features included in your subscription: Registering a National Drug Code (NDC) with the U.S. Food and Drug Administration (FDA) is part of the drug listing process. The NDC is a unique identifier assigned to each drug product, and it is used for product identification and [...]

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US FDA Drug Import License Register

Features included in your subscription: To import drugs into the United States, you must comply with the regulations set by the U.S. Food and Drug Administration (FDA). The FDA does not issue a specific “Drug Import License” but requires drug importers to register their establishments and follow specific procedures. Here’s [...]

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US FDA Agent Registration Service

The U.S. Food and Drug Administration (FDA) requires foreign establishments that manufacture, process, pack, or store FDA-regulated products to have a designated U.S. Agent. The U.S. Agent serves as a point of contact between the FDA and the foreign establishment. Here is an overview of the FDA Agent service: 1. [...]

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US FDA 510 (k) Registration

US FDA 510 (k) Registration Features included in your subscription: The U.S. Food and Drug Administration (FDA) 510(k) registration process is specifically related to the clearance of medical devices. The 510(k) pathway is used to demonstrate that a new medical device is substantially equivalent to a predicate device that is [...]

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The US FDA Establishment Identifier (FEI) number

The US FDA Establishment Identifier (FEI) number The FDA Establishment Identifier (FEI) number is a unique identifier assigned by the U.S. Food and Drug Administration (FDA) to regulated establishments. This number is used to track and identify establishments that manufacture, process, pack, or hold FDA-regulated products. Here’s an overview of [...]

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Apple App Approval Issues

Apple App Approval Issues If you’re experiencing issues with the approval of your app on the Apple App Store, there could be several reasons behind it. Here are some common issues and suggestions on how to address them: 1. Non-compliance with App Store Guidelines: Apple has strict guidelines that govern [...]