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By - SebastianFeye

An Overview of FDA Inspections across Drugs, Biologics and Medical Devices

The Food and Drug Administration (FDA) primary responsibility is the enforcement of the Federal Food, Drug and Cosmetic (FD&C) Act that tasked the agency with protecting and promoting public health and authorized the “legality of an FDA inspection, conducted at a reasonable time, within reasonable limits, and in a reasonable manner, depends not on consent but on the validity of

By - SebastianFeye

How to Register a Hand Sanitizer Product in the US

Due to the COVID-19 pandemic, world-wide demand has soared for hand sanitizer and anti-viral products. Below, we outline five basic steps for domestic and foreign manufacturers or domestic distributors who want to get their drug product into the US market but never dealt with the FDA’s electronic drug registration and listing. The scope of products includes: Rx (Prescription Drugs) and