Latest Advisory

  • FDA ASSURES PHARMACISTS GROUP

    FDA ASSURES PHARMACISTS GROUP

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  • FDA Advisory No. 2017-080 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 6)

    FDA Advisory No. 2017-080 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 6)

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  • FDA Advisory No. 2017-079 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 5)

    FDA Advisory No. 2017-079 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 5)

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  • FDA Advisory No. 2017-076 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 2)

    FDA Advisory No. 2017-076 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 2)

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  • FDA Advisory No. 2017-075 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 7)

    FDA Advisory No. 2017-075 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 7)

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  • FDA Advisory No. 2017-135 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

    FDA Advisory No. 2017-135 || Public Health Warning Against the Purchase and Consumption of the Following Unregistered Food Products and Food Supplements:

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  • FDA Advisory No. 2017-134 || Public Health Warning Against the Purchase and Consumption of Unregistered Food Products and Food Supplement

    FDA Advisory No. 2017-134 || Public Health Warning Against the Purchase and Consumption of Unregistered Food Products and Food Supplement

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  • FDA Advisory No. 2017-117 || Public Health Warning Against the Purchase and Consumption of Unregistered Food Products

    FDA Advisory No. 2017-117 || Public Health Warning Against the Purchase and Consumption of Unregistered Food Products

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  • FDA Advisory No. 2017-115 || Public Health Warning Against the Purchase and Consumption of Unregistered Food Supplements

    FDA Advisory No. 2017-115 || Public Health Warning Against the Purchase and Consumption of Unregistered Food Supplements

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  • FDA Advisory No. 2017-133-A ||Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na “Clotrimazole Vaginal Tablets I.P. (Canesten V6)” na Ginawa ng Bayer Pharmaceutical Pvt. Ltd. - INDIA

    FDA Advisory No. 2017-133-A ||Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na “Clotrimazole Vaginal Tablets I.P. (Canesten V6)” na Ginawa ng Bayer Pharmaceutical Pvt. Ltd. - INDIA

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  • FDA Advisory No. 2017-133 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product “Clotrimazole Vaginal Tablets I.P. (Canesten V6)” Manufactured by Bayer Pharmaceutical Pvt. Ltd. – INDIA

    FDA Advisory No. 2017-133 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product “Clotrimazole Vaginal Tablets I.P. (Canesten V6)” Manufactured by Bayer Pharmaceutical Pvt. Ltd. – INDIA

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  • FDA ISSUES CEASE AND DESIST ORDER AGAINST SANOFI, WATSON'S

    FDA ISSUES CEASE AND DESIST ORDER AGAINST SANOFI, WATSON'S

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  • FDA Advisory No. 2017-096 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplements:

    FDA Advisory No. 2017-096 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplements:

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  • FDA Advisory No. 2017-130 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 35)

    FDA Advisory No. 2017-130 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 35)

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  • FDA Advisory No. 2017-129 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 34)

    FDA Advisory No. 2017-129 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 34)

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  • FDA Advisory No. 2017-128 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 33)

    FDA Advisory No. 2017-128 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 33)

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  • FDA Advisory No. 2017-127 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 32)

    FDA Advisory No. 2017-127 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 32)

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  • FDA Advisory No. 2017-126 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 31)

    FDA Advisory No. 2017-126 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 31)

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  • FDA Advisory No. 2017-125 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 30)

    FDA Advisory No. 2017-125 || Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 30)

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  • FDA Advisory No. 2017-124 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 9)

    FDA Advisory No. 2017-124 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 9)

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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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