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Food and Drug Administration

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Circulars Circular No. 2020-033-B

Addendum to FDA Circular No. 2020-033 "Procedure for the Use of the Modified Electronic Registration System for Raw Materials and Prepackaged Processed Food Products" Repealing FDA Circular No. 2016-014 "Procedure for the Use of Electronic Registration System for Prepackaged Processed Food Products" to Include Process Steps for the Correction of Certificate of Product Registration, Additional Guidelines in Accomplishing Online Application Form, to Include the Requirements Stipulated in FC No. 2021-028, and Express Repeal of Relevant FDA Issuances for this Purpose."

Food and Drug Administration

Issued 2023-03-31 Filed 2023-04-13 ONAR 23-0392

Circulars Circular No. 2021-002-C

Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A entitled "Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No.2018-0002 "Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements"

Food and Drug Administration

Issued 2023-03-29 Filed 2023-04-13 ONAR 23-0392

Circulars Circular No. 2022-004-A

Amendment to FDA Circular No. 2022-004 entitled "Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals" to include Generic Drug Registration Applications and update the list of Reference Drug Regulatory Agencies

Food and Drug Administration

Issued 2023-02-15 Filed 2023-02-16 ONAR 24-00195