Cosmetic Labeling FDA requirements may vary based on the intended use of the product. A cosmetic with drug claims may be considered as a drug. How does FDA define Cosmetic? A...
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FDA fee for OTC drugs – OTC monograph Drug User fee
The FDA has published the OTC monograph Drug User fee for the fiscal year 2021. FDA refers to the OTC monograph Drug User Fee Program as “OMUFA”. FDA fee for OTC drugs...
FDA Registration Renewal timelines – when to renew your FDA registration.
Generally, FDA registration renewal timelines are from October 1 to December 31 every year. However, the annual registration requirement may vary based on the product category....
How to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer
In this article, you will understand how to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer. This article will be helpful for...
FDA establishment registration fee FY 2021
FDA registration fee FY 2021 FDA has published the annual establishment registration fee for FY 2021, which will be effective from October 1, 2020. The FDA registration fee for...
Understanding FDA temporary policy for Hand sanitizer -Updated 15th April 2020
Understanding Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry To prepare...