FDA Circular No.2020-024-B || Supplemental Guidelines to FDA Circular No. 2020-024 A, Entitled, “Amendment to FDA Circular No. 2020-024, Entitled Updated Guidelines for Application of Authorizations with the Food and Drug Administration in light of the Community Quarantine Declarations”

I. BACKGROUND        The Food and Drug Administration issued FDA Circular No. 2020-024, entitled, “Updated Guidelines for Application of Authorizations with the Food and Drug Administration in Light […]

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.2021-013 || Interim Guidelines of the Center for Food Regulation and Research (CFRR) for the Application and Receiving of Sales Promo Permit Applications in Compliance to the Republic Act No. 11032 otherwise known as The Ease of Doing Business and Efficient Government Service Delivery Act Of 2018

I. INTRODUCTION The passing of Republic Act (RA) No. 11032, otherwise known as the “Ease of Doing Business and Efficient Government Service Delivery Act of 2018” has led to streamlining […]

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 […]