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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FDA Circular No. 2017-010

Subject:  New Collection Policy and Procedure

I. Rationale

Republic Act No. 9485, also known as Anti-Red Tape Act of 2007, was enacted to improve efficiency in the delivery of government service to the public and to establish effective practices aimed at the prevention of graft and corruption. This law mandates all government agencies and officers to take appropriate measures to promote transparency with regard to the manner of transacting with the public

to continue reading download attachment...

 

Period to Accept Petitions/Oppositions Relative to the Recertification of Contraceptive Products Ended Last 31 August 2017

On 21 August 2017, FDA issued Advisory No. 2017-253 to formally begin the recertification process. 

FDA Advisory No. 2017-253 opened to the public the details of the contraceptive products subject to recertification and provided the mechanics for submitting petitions and corresponding evidence on their abortifacient or non-abortifacient properties. 

Also provided in FDA Advisory No. 2017-253 is the deadline for their submission which is ten (10) calendar days from the date of posting and publication.  Said Adivsory was posted at the FDA’s website, www.fda.gov.ph, on 21 August 2017 and published in 2 newspapers of general circulation, namely, The Philippine Star and the Manila Times, on 21 August 2017.  

August 31 marks the tenth day of the posting and publication of FDA Advisory No. 2017-253.   

FDA hereby formally concludes the submission period and will proceed with the review phase of the recertification process taking due consideration of the petitions submitted and their supporting evidence.

FDA Circular No. 2017-009

Guidelines on the Requests for Refund of Payments made to the Food and Drug Administration Offices

The Food and Drug Administration (FDA), in the exercise of its functions, issues, license, permits and certifications to the establishments engaged in the manufacture, distribution, trade, and/or sale of health products and for products that are placed in the market. These services involve the consumption of resources that entail cost and expenditure to the agency. As such, the agency uses charges and fees to fund its services. In cases where there are overpayments or erraneous payments made by client due to circumstances beyond their control, the agency shall provide opportunities to refund payments made.

Attachments:
Download this file (FC2017-0009.pdf)FC2017-0009.pdf

Compliance with the Supreme Court Resolution Regarding the Recertification and Certification of Contraceptive Products

On 26 April 2017, the Supreme Court (SC) issued a Resolution ordering the Food and Drug Administration (FDA) to consider “the oppositions filed by Alliance for the Family Foundation, Inc. (ALFI) with respect to the listed drugs, including Implanon and Implanon NXT, based on the standards of the Reproductive Health Law, as construed in Imbong vs. Ochoa, and to decide the case within sixty (60) days from the date it will be deemed submitted for resolution”. 

Consequently, the FDA issued on 21 August 2017 Advisory No. 2017-253 to begin the recertification process for the listed products. 

FDA wishes to advice the public that—  

1) For the recertification process, the FDA will no longer issue any additional guidelines as the provisions in RA 10354 and its Implementing Rules and Regulations, and the decision of the High Court in ALFI vs. Garin et al. are already clear. 

2) For the certification process of new reproductive health products, the draft of the revised IRR will contain the guidelines that will be implemented by the FDA in the registration process. As a matter of procedure, a public consultation will be scheduled and held to give opportunity to the public to comment on this. 

The FDA is determined to do its part by exerting all efforts to consider the oppositions filed and decide on their merits accordingly.

The FDA is mindful of its responsibility to comply with the SC’s decision, and to uphold the mandates of due process, both geared towards the goal of ensuring and protecting public health.

FDA to commence re-certification process of contraceptive products.

The FDA will issue a formal announcement for the commencement of the recertification process of the listed contraceptive products on Monday, 21 August, in compliance with the Supreme Court's Decision in Alliance for the Family Foundation Inc., vs. Sec. Garin et al.

The announcement will contain the following:
(1) list and details of the contraceptive products (i.e., generic and brand name [if any], dosage form and strength, and registration numbers) for recertification,
and (2) the mechanics for submitting comments/petitions in support of, or in opposition to [with supporting evidence], the recertification, by the public, and concerned groups/individuals.

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