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Tag: drug

Last Updated on May 21, 2021
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Posted in BLOG, FDA Updates
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Leave a Comment on 2020 Over-the-Counter (OTC) Drug Monographs Reform Summary

By - SebastianFeye

2020 Over-the-Counter (OTC) Drug Monographs Reform Summary

Updated: March 26, 2021 – FDA has stated that MDF facility fees will be $20,322, and CMO facility fees will be $13,548. Over-the-Counter (OTC) drug monographs represent current regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and

Tagged : Adminstration, CARES Act, drug, drugs, FDA, Food, Food and Drug Administration, GRASE, Medicine, monograph, OMOR, OTC Monograph Order Request, Over-the-counter, Program, reform, User fees

Last Updated on May 11, 2020
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Posted in BLOG, How-To
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1 Comment on How to Register a Hand Sanitizer Product in the US

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

Tagged : anti-viral, API, data, DnB, drug, hand, Hand Sanitizer, labeler, listing, NDC code, OTC, registration, santizer