FDA Circular No. 2021-014 || Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Traders and Distributors including Wholesalers, Importers, and Exporters of Medical Devices, Equipment or Devices Used for Treating Sharps, Pathological and Infectious Waste and Water Treatment Devices/Systems

The objective of this Circular is to provide the guidelines on the FDA eServices Portal System in applying for LTO Application of Traders and Distributors including Wholesalers, Importers, and Exporters […]

FDA Circular No.2021-012 || Guidelines for the Use of the Food and Drug Administration (FDA) eServices Portal System for License to Operate (LTO) Application of Food Traders and Food Distributors Including Wholesalers, Importers, and Exporters of Processed Food Products, Food Supplements, Bottled Water, and Iodized Salt

I. BACKGROUND   In order to build efficient regulatory systems, the Food and Drug Administration (FDA) has undertaken process improvement initiatives, including the establishment of information and communication technology infrastructures […]

Clarification on the Approval and Use of Leronlimab

The Food and Drug Administration (FDA) clarifies that Leronlimab is not approved by the FDA for treatment of COVID-19. Leronlimab is an investigational product which is still undergoing clinical trials […]

FDA Advisory No.2020-0665-A || Lifting the Advisory on the Notified Cosmetic Product “COLOURETTE COLOURSNAPS MILKY” under FDA Advisory No. 2020-665 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic COLOURETTE MILK COLOURSNAP DEWY MULTI-STAIN” Dated 15 April 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product Colourette Coloursnaps Milky with 1000007447496, has been notified by the Market Authorization Holder, NIV DELLA BEAUTY INNOVATIONS […]