Latest Advisory

  • FDA Advisory No. 2017-329 || Voluntary Recall of  AV-Set B DT INF-E Blood Tubing System with DVR No. 8574 (Article No. AP16641)

    FDA Advisory No. 2017-329 || Voluntary Recall of AV-Set B DT INF-E Blood Tubing System with DVR No. 8574 (Article No. AP16641)

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  • FDA Advisory No. 2017-328 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 20)

    FDA Advisory No. 2017-328 || Public Health Warning Against the Use of Unregistered Household/Urban Pesticide Products (Batch 20)

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  • FDA Advisory No. 2017-327 || CREATION OF A TASK FORCE THAT WILL REVIEW, SUBMIT RECOMMENDATIONS AND TAKE APPROPRIATE ACTIONS RELATING TO THE DENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED), REGISTERED AS DENGVAXIA, AND THE TRANSMITTAL OF APPLICATIONS, LETTER

    FDA Advisory No. 2017-327 || CREATION OF A TASK FORCE THAT WILL REVIEW, SUBMIT RECOMMENDATIONS AND TAKE APPROPRIATE ACTIONS RELATING TO THE DENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED), REGISTERED AS DENGVAXIA, AND THE TRANSMITTAL OF APPLICATIONS, LETTER

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  • FDA Advisory No. 2017-326 || Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product:

    FDA Advisory No. 2017-326 || Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product:

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  • FDA Advisory No. 2017-322 || TERMINATION OF THE VOLUNTARY PRODUCT RECALLOF COBRA DISTAL RADIUS FIXATOR

    FDA Advisory No. 2017-322 || TERMINATION OF THE VOLUNTARY PRODUCT RECALLOF COBRA DISTAL RADIUS FIXATOR

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  • FDA Advisory No. 2017-325 || VOLUNTARY RECALL OF THE NASOPORE STANDARD 8CM NASAL DRESSING WITH PRODUCT REGISTRATION MDR NO. 02341

    FDA Advisory No. 2017-325 || VOLUNTARY RECALL OF THE NASOPORE STANDARD 8CM NASAL DRESSING WITH PRODUCT REGISTRATION MDR NO. 02341

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  • FDA Advisory No. 2017-323 || Public Health Warning Against False, Deceptive and Misleading Health Claims of Pantyliners

    FDA Advisory No. 2017-323 || Public Health Warning Against False, Deceptive and Misleading Health Claims of Pantyliners

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  • FDA Advisory No. 2017-321 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Firstaid Blood Lancets”

    FDA Advisory No. 2017-321 || Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Firstaid Blood Lancets”

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  • FDA Advisory No. 2017-320 || Public Health Warning Against the Use of Unregistered Medical Device (Sutures)

    FDA Advisory No. 2017-320 || Public Health Warning Against the Use of Unregistered Medical Device (Sutures)

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  • FDA Advisory No. 2017-324-A || Mga Paalala sa Publiko Ngayong Panahon ng Pasko

    FDA Advisory No. 2017-324-A || Mga Paalala sa Publiko Ngayong Panahon ng Pasko

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  • FDA Advisory No. 2017-324 || Reminders to the Public During the Holiday Season

    FDA Advisory No. 2017-324 || Reminders to the Public During the Holiday Season

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  • FDA Advisory No. 2017-319 || Public Health Warning Against the Purchase and Consumption of Unregistered and Unfortified Flour Products

    FDA Advisory No. 2017-319 || Public Health Warning Against the Purchase and Consumption of Unregistered and Unfortified Flour Products

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  • FDA Advisory No. 2017-316 || Public Health Warning Against the Purchase and Consumption   of the following Unregistered and Unfortified Food Oil  Products:

    FDA Advisory No. 2017-316 || Public Health Warning Against the Purchase and Consumption of the following Unregistered and Unfortified Food Oil Products:

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  • FDA Advisory No. 2017-318 || Suspension of Sale/Marketing/Distribution of Sanofi Pasteur, Inc.’s Tetravalent Vaccine (Live, Attenuated)(Dengvaxia)

    FDA Advisory No. 2017-318 || Suspension of Sale/Marketing/Distribution of Sanofi Pasteur, Inc.’s Tetravalent Vaccine (Live, Attenuated)(Dengvaxia)

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  • FDA Advisory No. 2017-317 || ACCEPTANCE OF ALL APPLICATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC) CASHIER

    FDA Advisory No. 2017-317 || ACCEPTANCE OF ALL APPLICATIONS AT THE FOOD AND DRUG ACTION CENTER (FDAC) CASHIER

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  • 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 Circular No. 2017-015

Adoptation of the ASEAN Cosmetic Directive (ACD) Annexes II and VI as Standards for Household/Urban Pesticides

 

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FDA Circular No. 2017-014

New Procedure in the Application of the Variation of Certificate of Product Registration for Medical Devices

I. Background

Republic ACt (RA) No. 3720 (Food, Drugs and Devices and Cosmetics Act), as amended by RA No. 9711 (Food and Drug Administration Act of 2009) were all enacted to establish an effective regulatory system for the authorization, registration and monitoring of health products.

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FDA Circular No. 2017-013

Guidelines on the Issuance of Clearance for Customs Release of Radiation Devices by the Food and Drug Administration - Center for Device Regulation, Radiation Health and Research

I RATIONALE / BACKGROUND

Pursuant to Section 1(a) of Presidential Decree (PD) No. 480 entitled "Creating Radiation Health Office in the Department" dated 06 June 1974 as amended by PD No. 1372 and under Republic Act No. 9711 also known as "The Food and Drug Administration Act of 2009", the Center for Device Regulation , Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (FDA) is empowered to regulate the import and export of radiation devices that can be ionizing such x-ray devices and non-ionizing such as laser, ultrasound, scanners and infrared radiation devices and others.

By virtue of FDA Personnel Order No. 2017-876, please be advised that the Center for Device Regulation Radiation Health and Research (CDRRHR) - Product Research and Standard Development Division (PRSDD) will be having a Consultative Workshop on Labeling of Medical Devices from December 20 - 22, 2017, On such dates, PRSDD will not be able to entertain clients nor accept document for processing.

Regular transactions resume on 27 December 2017.

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

ANNOUNCEMENT 

Postponement of the Conduct of The Licensing Seminar on A.O.34 For Drugstores and Outlets

Please be informed that the conduct of the Licensing Seminar on A.O. 34 for Drugstores and Outlets on 13 December 2017 and 19 December 2017, is POSTPONED and moved to FIRST QUARTER OF 2018

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