Latest Advisory

  • FDA Advisory No. 2017-270 || Invitation to Present Submitted Petitions and Corresponding Evidences in connection with the Re-certification of Contraceptive Products

    FDA Advisory No. 2017-270 || Invitation to Present Submitted Petitions and Corresponding Evidences in connection with the Re-certification of Contraceptive Products

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  • FDA Advisory No. 2017-266 || Public Health Warning Against the Use of Unnotified Toy and Childcare Article (TCCAs) Products (Batch 9)

    FDA Advisory No. 2017-266 || Public Health Warning Against the Use of Unnotified Toy and Childcare Article (TCCAs) Products (Batch 9)

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  • FDA Advisory No. 2017-267 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 15)

    FDA Advisory No. 2017-267 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 15)

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  • FDA Advisory No. 2017-269 || Public Health Warning Against Unapproved and Misleading Advertisements and Promotion of Unregistered MEICO PINUS PINE ENZOGENOL FOOD SUPPLEMENT Posted in Social Media

    FDA Advisory No. 2017-269 || Public Health Warning Against Unapproved and Misleading Advertisements and Promotion of Unregistered MEICO PINUS PINE ENZOGENOL FOOD SUPPLEMENT Posted in Social Media

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  • FDA Advisory No. 2017-166-A || Amendment to FDA Advisory No. 2017-166 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 43)” Dated 13 June 2017

    FDA Advisory No. 2017-166-A || Amendment to FDA Advisory No. 2017-166 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 43)” Dated 13 June 2017

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  • FDA Advisory No. 2017-265 || Public Warning Against Accessing Japanese Encephalitis Vaccine and other Vaccines from Online Sellers and other Unauthorized Distributors/Retailers

    FDA Advisory No. 2017-265 || Public Warning Against Accessing Japanese Encephalitis Vaccine and other Vaccines from Online Sellers and other Unauthorized Distributors/Retailers

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  • FDA Advisory No. 2017-264 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

    FDA Advisory No. 2017-264 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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  • FDA Advisory No. 2017-263 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

    FDA Advisory No. 2017-263 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

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  • FDA Advisory No. 2017-262 || Public Health Warning Against the following Unregistered Food Supplements with their Corresponding Unapproved and Misleading Advertisements and Promotion:

    FDA Advisory No. 2017-262 || Public Health Warning Against the following Unregistered Food Supplements with their Corresponding Unapproved and Misleading Advertisements and Promotion:

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  • FDA Advisory No. 2017-261 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

    FDA Advisory No. 2017-261 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

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  • FDA Advisory No. 2017-260 || Public Health Warning on Art Coloring Products with Detected Levels of Lead

    FDA Advisory No. 2017-260 || Public Health Warning on Art Coloring Products with Detected Levels of Lead

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  • Duterte backs FDA thrusts

    Duterte backs FDA thrusts

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  • FDA Advisory No. 2017-055-B || Amendment to FDA Advisory No. 2017-055 “Public Health Warning Against the Use of Unnotified Toy and Childcare Article (TCCAs) Products (Batch 2)”

    FDA Advisory No. 2017-055-B || Amendment to FDA Advisory No. 2017-055 “Public Health Warning Against the Use of Unnotified Toy and Childcare Article (TCCAs) Products (Batch 2)”

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  • FDA Advisory No. 2017-259 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplements:

    FDA Advisory No. 2017-259 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplements:

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  • FDA Advisory No. 2017-258 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Krystall Herbal Oil

    FDA Advisory No. 2017-258 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Krystall Herbal Oil

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  • FDA Advisory No. 2017-258-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Krystall Herbal Oil

    FDA Advisory No. 2017-258-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Krystall Herbal Oil

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  • FDA Advisory No. 2017-257 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Hydrogen Peroxide (Agua Oxigenada)10 Volumes Repacked by Secret Love Enterprises – Valenzuela, M.M.

    FDA Advisory No. 2017-257 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Hydrogen Peroxide (Agua Oxigenada)10 Volumes Repacked by Secret Love Enterprises – Valenzuela, M.M.

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  • FDA Advisory No. 2017-257-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Hydrogen Peroxide (Agua Oxigenada) 10 Volumes Repacked by Secret Love Enterprises – Valenzuela, M.M.

    FDA Advisory No. 2017-257-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Hydrogen Peroxide (Agua Oxigenada) 10 Volumes Repacked by Secret Love Enterprises – Valenzuela, M.M.

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  • FDA Advisory No. 2017-256 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product GIGA Tea Tree Oil Solution

    FDA Advisory No. 2017-256 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product GIGA Tea Tree Oil Solution

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  • FDA Advisory No. 2017-256-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na GIGA Tea Tree Oil Solution

    FDA Advisory No. 2017-256-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na GIGA Tea Tree Oil Solution

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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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