Latest Advisory

  • FDA Advisory No. 2015-048 || Recall of all Drug Products Manufactured by Allied Pharmaceutical Laboratories, Inc. from January 2014 Up to the Present

    FDA Advisory No. 2015-048 || Recall of all Drug Products Manufactured by Allied Pharmaceutical Laboratories, Inc. from January 2014 Up to the Present

    Read more

  • FDA Advisory No. 2015-047 || RECALL OF SPECIFIC BATCH OF FUROSEMIDE (AS SODIUM) 10 MG/ML (20 MG/2 ML) SOLUTION FOR INJECTION (IV/IM) WITH BRAND NAME LASIX

    FDA Advisory No. 2015-047 || RECALL OF SPECIFIC BATCH OF FUROSEMIDE (AS SODIUM) 10 MG/ML (20 MG/2 ML) SOLUTION FOR INJECTION (IV/IM) WITH BRAND NAME LASIX

    Read more

  • FDA Advisory No. 2015-046 || RECALL OF ALL DRUG PRODUCTS MANUFACTURED BY DOCTORS PHARMACEUTICALS, INC. FROM MARCH 2014 UP TO THE PRESENT

    FDA Advisory No. 2015-046 || RECALL OF ALL DRUG PRODUCTS MANUFACTURED BY DOCTORS PHARMACEUTICALS, INC. FROM MARCH 2014 UP TO THE PRESENT

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  • FDA Advisory No. 2015-045 || RECALL OF ALL BATCHES OF BUMETANIDE (BURINEX) 500 mcg/mL SOLUTION FOR INJECTION (I.M./I.V.)

    FDA Advisory No. 2015-045 || RECALL OF ALL BATCHES OF BUMETANIDE (BURINEX) 500 mcg/mL SOLUTION FOR INJECTION (I.M./I.V.)

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  • FDA Advisory No. 2015-043 || Public Health Advisory on the Alleged Durian Candy “Wendy’s” Brand Poisoning in CARAGA Region

    FDA Advisory No. 2015-043 || Public Health Advisory on the Alleged Durian Candy “Wendy’s” Brand Poisoning in CARAGA Region

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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

 

Announcement

BAC ADVISORY NO. 2014-002
(ITB No. 14-019)

Construction of FDA Walkway, Waiting Shed, Steel Gate and Perimeter Fence

Subject : Re-Scheduled of PRE-BID CONFERENCE

09 December 2014

The PRE-BID CONFERENCE for the above subject project was not transpired on 08 December 2014 due to TYPHOON RUBY that caused work cancellation of all government offices in the National Capital Region (NCR).

In view thereof, all prospective bidders advised that the PRE-BID CONFERENCE is hereby re-scheduled on 11 December 2014 at 2:00pm, AFO Conference Room

For information and guidance of all concerned.

ANNOUNCEMENT

Application for Registration of Raw Materials and Low Risk Pre-Packaged Processed Food Products

In accordance with FDA Circular No. 2014-0029 entitled "Procedure for the Use of Electronic Registration (E-Registration) System for Raw Materials or Ingredients and Low Risk Pre-packaged Processed Food Products," all low risk food products as listed in Annex A of attached AO2014-0029 and raw materials shall be applied online through electronic registration. Following the said circular, the Public Assistance Information and Receiving (PAIR) Unit shall no longer receive application for the raw materials and low risk food products.

For information and guidance

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

Cosmetic Safety Assessment and Product Information file

What : Cosmetic Safety Assessment and Product Information file
When : 24 November 2014, 8:30 AM - 5:30 PM
(Registration Starts at 8:00 AM)
Where : Crimson Hotel Filinvest City, Manila
Entrata Urban Complex, 2609 Civic Drive,
Filinvest City, Alabang Muntilupa City 1781, Philippines

Announcement

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  • To: All Concerned Drug Establishment

    Subject: Updated Schedule for Pharmacy Assistant Summit

     

    Date

    Location

    Venue

    July 10 Bulacan THE REGENCY BALIUAG
    (R.E Chico St. Brgy Concepcion, Baliuag, Bulacan)
    July 20 Baguio PRINCE PLAZA HOTEL
    (17 Legarda Rd, Baguio, Benguet, Philippines)
    July 23 Davao YAHONG RESTAURANT
    (Torres St., Davao City)
    July 25 Koronadal VILLA AMOR HOTEL
    (Santos Drive Koronadal, Marbel 8, South Cotabato)
    July 26 General Santos Lola Sisay Hotel and Restaurant
    (Catholic Avenue, Gen Santos Ave.)
    July 27 Pagadian HOTEL ALINDAHAW
    (Rizal Avenue, Pagadian City, Zamboanga del Sur)
    Aug 7 Tarlac URDU RESTAURANT AND BAKESHOP
    (71 P. Burgos St. Cut Cut 1st, San Vicente, Tarlac City)
    Aug 10 Olongapo SUBIC BAY PENINSULAR HOTEL
    (Canal Rd, Subic Bay Freeport Zone, 2200 Zambales, Philippines)
    Aug. 16 Quezon-Marinduque QUEEN MARGARETTE HOTEL DOWNTOWN
    (M.L. Tagarao St. Granja St. Lucena City)
    Aug 17 Laguna DAVID'S TEA HOUSE
    (8440 Lecheria Halang, Calamba, Laguna)
    Aug 19 Butuan BIG DADDY CONVENTION CENTER
    (JC Aquino Ave.)
    Aug 25 Capiz GRAND GAZEEBO
    (Baybay, Roxas City)
    Aug 26 Aklan NANETTE'S RESTO
    (Roxas Ave., Extension, Kalibo, Aklan)
    Aug 29 Laoag LAOAG RENZO HOTEL
    (Rizal St. Cor. Guerrero)
    Aug 31 Iligan DOWNTOWN FRIED CHICKEN AND STEAKHOUSE
    (Mariano Badelles Sr. Iligan City)
    Sept 7 Mindoro Oriental, Calapan VENCIO'S HOTEL AND RESTAURANT
    (Brgy. Tawiran, Calapan City)
    Sept 13 Iloilo/Guimaras TBA
    Sept 16 La Unippon TBA
    Nov 6 Bacolod TBA
    Nov 11 Dumaguete TBA
    Nov 17 Naga, Bicol TBA
    Nov 21 Bohol TBA

     

  • ANNOUNCEMENT

    Date : 20 March 2015

    To : All FDA-Regulated Establishment Applying for License to Operate (LTO), Certificate of Product Registration (CPR), and Other Authorizations Following the Public Assistance, Information and Receiving (PAIR) Process.

    Subject : Request for Rescheduling of Appointment/Submission

    Effective 16 April 2015, request for rescheduling of appointment for the submission of License to Operate, Certificate of Product Registration, and Other Authorizations following the PAIR Process should be coursed thru the e-mail account: This email address is being protected from spambots. You need JavaScript enabled to view it. following the hereunder format -

    To : This email address is being protected from spambots. You need JavaScript enabled to view it.
    Subject : Rescheduling of Appointment, 14-digit DTN
    Body: Application type (initial, renewal,re-application, etc.); for renewal application, please indicate expiry/validity
    date of current LTO/CPR

    The PAIR Unit will grant request for another appointment schedule only once, thus, applicant companies are advised to prepare all requirement, i.e. documentary, technical and financial, before sending an e-mail request. Further, to avoid inconveniences and payment of surcharge, applicants are highly encouraged to file renewal application as prescribed by existing regulations.

    For your information, guidance and compliance

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