Latest Advisory

  • FDA Advisory No. 2017-013 || Reiteration of the Public Health Warning Against the Use of Max Factor Eye Brightening Mascara

    FDA Advisory No. 2017-013 || Reiteration of the Public Health Warning Against the Use of Max Factor Eye Brightening Mascara

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  • FDA Advisory No. 2017-012 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 10

    FDA Advisory No. 2017-012 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 10

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  • FDA Advisory No. 2017-011 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 9)

    FDA Advisory No. 2017-011 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 9)

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  • FDA Advisory No. 2017-010 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 8)

    FDA Advisory No. 2017-010 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 8)

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  • FDA Advisory No. 2017-009 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 7)

    FDA Advisory No. 2017-009 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 7)

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  • FDA Advisory No. 2017-008 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 6)

    FDA Advisory No. 2017-008 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 6)

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  • FDA Advisory No. 2017-007 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 5)

    FDA Advisory No. 2017-007 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 5)

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  • FDA Advisory No. 2017-006 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 4)

    FDA Advisory No. 2017-006 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 4)

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  • FDA Advisory No. 2017-005 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 3)

    FDA Advisory No. 2017-005 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 3)

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  • FDA Advisory No. 2017-004 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (batch 7)

    FDA Advisory No. 2017-004 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (batch 7)

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  • FDA Advisory No. 2017-003 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 2)

    FDA Advisory No. 2017-003 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 2)

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  • FDA Advisory No. 2017-002 || Lifting of FDA Advisory No. 2016-143 and 2016-143-A, “Public Health Warning Against the Use of Unregistered Drug Product Puritan’s Pride Folic Acid 400 mcg Tablet”

    FDA Advisory No. 2017-002 || Lifting of FDA Advisory No. 2016-143 and 2016-143-A, “Public Health Warning Against the Use of Unregistered Drug Product Puritan’s Pride Folic Acid 400 mcg Tablet”

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  • FDA Advisory No. 2017-001 || Public Warning Against the Facebook Group “DAIRY GOAT PHILIPPINES” for Promoting Dairy Goat as Breastmilk Substitute for Infants and Violating Executive Order No. 51 or the “Milk Code of the Philippines”

    FDA Advisory No. 2017-001 || Public Warning Against the Facebook Group “DAIRY GOAT PHILIPPINES” for Promoting Dairy Goat as Breastmilk Substitute for Infants and Violating Executive Order No. 51 or the “Milk Code of the Philippines”

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  • FDA Advisory No. 2016-146 || Public Health Advisory on Lead-Cored Wick Candles

    FDA Advisory No. 2016-146 || Public Health Advisory on Lead-Cored Wick Candles

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  • FDA Advisory No. 2016-145 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 23)

    FDA Advisory No. 2016-145 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 23)

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  • FDA Advisory No. 2016-144-A || Babala sa Publiko Tungkol sa Paggamit ng Hindi Rehistradong Gamot na “Sevelamer Hydrochloride (Sevel) 400 mg Tablet” na gawa ng The ACME Laboratories Ltd. – Dhaka, Bangladesh

    FDA Advisory No. 2016-144-A || Babala sa Publiko Tungkol sa Paggamit ng Hindi Rehistradong Gamot na “Sevelamer Hydrochloride (Sevel) 400 mg Tablet” na gawa ng The ACME Laboratories Ltd. – Dhaka, Bangladesh

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  • FDA Advisory No. 2016-144 || Public Health Warning Against the Use of the Unregistered Drug Product “Sevelamer Hydrochloride (Sevel) 400 mg Tablet” manufactured by The ACME Laboratories Ltd. – Dhaka, Bangladesh

    FDA Advisory No. 2016-144 || Public Health Warning Against the Use of the Unregistered Drug Product “Sevelamer Hydrochloride (Sevel) 400 mg Tablet” manufactured by The ACME Laboratories Ltd. – Dhaka, Bangladesh

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  • FDA Advisory No. 2016-142-A || Babala sa Publiko Tungkol sa Paggamit ng mga Hindi Rehistradong Gamot na:

    FDA Advisory No. 2016-142-A || Babala sa Publiko Tungkol sa Paggamit ng mga Hindi Rehistradong Gamot na:

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  • FDA Advisory No. 2016-142 || Public Health Warning Against the Use of the Following Unregistered Drug Products:

    FDA Advisory No. 2016-142 || Public Health Warning Against the Use of the Following Unregistered Drug Products:

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  • FDA Advisory No. 2016-141-A || Babala sa Publiko tungkol sa Paggamit ng mga Pekeng Gamot na:

    FDA Advisory No. 2016-141-A || Babala sa Publiko tungkol sa Paggamit ng mga Pekeng Gamot na:

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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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