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Cosmetic Labeling FDA requirements June 25, 2021

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 product used on the human body to clean, beautify, and improve the appearance without affecting the human body’s structure or functions is considered a … Continue reading Cosmetic Labeling FDA requirements .... Read More

FDA fee for OTC drugs – OTC monograph Drug User fee January 4, 2021

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 explained     Who has to pay the OTC monograph Drug User Fee?   Facilities that are engaged in the manufacturing or processing of the … Continue reading FDA fee for OTC drugs – OTC monograph Drug User fee .... Read More

FDA Registration Renewal timelines – when to renew your FDA registration. September 11, 2020

  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. Summary of FDA registration renewal requirements.     Food facility registration renewal timelines   Food facilities registration is required every even year between the 1st of October and … Continue reading FDA Registration Renewal timelines – when to renew your FDA registration. .... Read More

How to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer September 7, 2020

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 companies manufacturing and importing hand sanitizer into the USA.   Even though hand sanitizer containing OTC ingredients (Alcohol and benzalkonium chloride) does not require prior approval … Continue reading How to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer .... Read More

FDA establishment registration fee FY 2021 August 12, 2020

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 each medical device establishment is $5,546. All medical device establishments intended to register/renew their facility are required to pay the establishment registration fee. Waivers or reductions … Continue reading FDA establishment registration fee FY 2021 .... Read More

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