Latest Advisory

  • FDA Advisory No. 2017-315 || Voluntary Recall of BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube, 13 x 75mm x 2.0mL

    FDA Advisory No. 2017-315 || Voluntary Recall of BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube, 13 x 75mm x 2.0mL

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  • FDA Advisory No. 2017-314 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 67)

    FDA Advisory No. 2017-314 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 67)

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  • FDA Advisory No. 2017-313 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 13)

    FDA Advisory No. 2017-313 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 13)

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  • FDA Advisory No. 2017-312 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 12)

    FDA Advisory No. 2017-312 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 12)

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  • FDA Advisory No. 2017-311 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

    FDA Advisory No. 2017-311 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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  • FDA Advisory No. 2017-310 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

    FDA Advisory No. 2017-310 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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  • FDA Advisory No. 2017-309 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

    FDA Advisory No. 2017-309 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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  • FDA Advisory No. 2017-308 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

    FDA Advisory No. 2017-308 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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  • FDA Advisory No. 2017-307 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 63)

    FDA Advisory No. 2017-307 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 63)

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  • FDA Advisory No. 2017-306 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 11)

    FDA Advisory No. 2017-306 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 11)

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  • FDA Advisory No. 2017-305 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 10)

    FDA Advisory No. 2017-305 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 10)

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  • FDA Advisory No. 2017-304 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 9)

    FDA Advisory No. 2017-304 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 9)

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  • FDA Advisory No. 2017-303 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements Claiming to Contain L-Glutathione:

    FDA Advisory No. 2017-303 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Supplements Claiming to Contain L-Glutathione:

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  • FDA Advisory No. 2017-297 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

    FDA Advisory No. 2017-297 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

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  • FDA Advisory No. 2017-299 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 19)

    FDA Advisory No. 2017-299 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 19)

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  • FDA Advisory No. 2017- 296 || Public Health Warning Against the Use of Unnotified Toy and Childcare Article (TCCAs) Products (Batch 11)

    FDA Advisory No. 2017- 296 || Public Health Warning Against the Use of Unnotified Toy and Childcare Article (TCCAs) Products (Batch 11)

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  • FDA Advisory No. 2017-298 || Reiteration of FDA Advisory No. 2017-212 entitled “Public Health Warning Against the Purchase and Use of Unregistered Health Related Device (Water Purification Device) Biocera Alkaline Antioxidant Stick, FDA Advisory No. 2014-

    FDA Advisory No. 2017-298 || Reiteration of FDA Advisory No. 2017-212 entitled “Public Health Warning Against the Purchase and Use of Unregistered Health Related Device (Water Purification Device) Biocera Alkaline Antioxidant Stick, FDA Advisory No. 2014-

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  • FDA Advisory No. 2017- 301 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

    FDA Advisory No. 2017- 301 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

    Read more

  • FDA Advisory No. 2017-300 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

    FDA Advisory No. 2017-300 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

    Read more

  • FDA Advisory No. 2017-295 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 8)

    FDA Advisory No. 2017-295 || Public Health Warning Against the Use of Counterfeit Cosmetic Products (Batch 8)

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Additional Instruction for Letters, Commercial Samples, and Approved Labels for Post-Marketing Surveillance (PMS) Purposes to be Submitted to the Center for Drug Regulation and Research

Consistent with the issuance of FDA Memorandum dated 14 august 2014 regarding the Receiving of Product Application and Letter, and to facilitate the processing of related services and regulatory processes, all concerned stakeholders are requested to comply with the following additional instructions:

- For letters, kindly provide contact details (e.g. telephone number(s) and/or e-mail address(es). This will allow online viewing of the letter vial DocTrack at http://www.fda.gov.ph/doctrack-status-know-the-status-of-your-application and minimize the need for the follow-up on the part of the stakeholder.

- For labels submitted as part of post-approval commitment, kindly include copies of the labeling materials as corrected by CDRR. This will facilitate the review and filling of the process of FDA.

- For commercial samples submitted as part of post-approval commitment, kindly include copies of the approved labeling material(s). This will facilitate the review and filling process of FDA.

As part of transparency and rendering faster processing of the above mentioned submissions, instead of issuing acknowledgement letters, FDA shall acknowledgement via DocTrack.

For your information and compliance

Attachments:
Download this file (announcement.pdf)announcement.pdf

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