Draft for Comments || Extension of 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””

All comments may be sent to [email protected]. The deadline for submission of comments is on 22 February 2024. I. RATIONALE FDA Circular (FC) No. 2021-002-A was issued on 9 August […]

Draft for Comments || Guidelines for the Classification of Vitamins and Minerals for Food/Dietary Supplements under Processed Food Product Repealing the Provisions for Food in the Office Order No. 22 s. 1991 entitled “Guidelines for the Classification of Vitamins and Minerals as Drug or as Food”

Please be informed that the CFRR has drafted the attached FDA Circular entitled “Guidelines for the Classification of Vitamins and Minerals for Food/Dietary Supplements under Processed Food Product Repealing the […]

Draft for Comments || 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

All comments may be sent to [email protected]. The deadline for submission of comments is on 05 January 2024.   In the continuous effort to streamline regulatory processes and adopt good […]

Draft for Comments || Submission of Position Paper/Comments on the Draft Administrative Order entitled “Implementing Guidelines on the Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services Repealing Administrative Order No. 50s. 2001, “Revised 2001 Schedule of Fees and Charges for the Corresponding Services Rendered by the Bureau of Food and Drugs” and its Amendments

This refers to the public consultation on the FDA’s new schedule of Fees and Charges conducted virtually on 27 October 2023 and face-to-face on 29-30 November 2023. All concerned FDA […]