Latest Advisories

  • FDA Advisory No. 2014-078 || Product Recall of Lot Specific Rifampicin 450 mg Capsule (PICINAF)

     

  • FDA Advisory No. 2014-077 || Product Recall of Lot Specific Cefaclor (As Monohydrate) 50mg/mL Powder for Suspension (Oral Drops) with Brand Name CECLOBID

  • FDA Advisory No. 2014-076 || Voluntary Recall of Lot Specific Doxorubicin Hydrochloride 2 mg/mL (20 mg/10 mL) Pegylated Liposomal Concentrate for I.V. Infusion (CASPRIA)

  • FDA Advisory No. 2014-075 || Public warning against false, deceptive and misleading claims of Turcumin Herbal Food Supplement Advertised in The Philippine Star and Bulgar

     

  • FDA Advisory No. 2014-074 || Recall of Specific Batches of Tetrahydrozoline Hydrochloride (Visine) 0.5 mg/mL (0.05%) Ophthalmic Solution (Eye Drops)

     

Public Hearing on the New Guideline on Medical Device Registration

TO : Medical Device Industries
When : 3 November 2014, 9:00 am - 12:00 pm
Public Hearing on the New Guidelines on Medical Device Registration
Where : 3/F, AVR, Annex Building Food and Drug Administration,
Alabang, Muntinlupa City

For efficiency, participants shall register online through This email address is being protected from spambots. You need JavaScript enabled to view it. with the following prescribed format below:

Email Subject  Public Hearing on the New Guideline on Medical Device Registration
Body of Email
Name of Participant : Last Name, First Name, MI.
Company Name  
Contact No(s)  
Email Address  

A confirmation slip will be sent as a reply, please bring a copy of your confirmation slip on the day of Public Consultation

For your information, guidance, and compliance

Issuance of FDA Official Receipt for Bank Payments

This is to inform the public that effective 13 October 2014, the release/issuance of Official Receipt for all bank payments of FDA Fees and Charges will be through our Cashier from 8:00 a.m. to 5:00 p.m.  This will also cover all unclaimed Official Receipt from previous months.

 

Validated payment slip must be submitted in exchange to the Official Receipt that we will issue.  Issuance of Official Receipt will be 3-5 working days after your bank payment was made.

 

Please be guided accordingly.

 

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

Announcement

  • Temporary Suspension of Procurement for ITB 14-017

     BAC ADVISORY 2014-001

    for ITB 14-017

    Procurement and Delivery of One (1) Year Locked in Period and Shall be Deemed Renewed until Terminated for Consumable Supply with Fifty (50) Units Complimentary Free Use of Printers 4 in 1 Monochrome

    This is to inform all prospective bidders that the Procurement and Delivery of One (1) Year Locked in Period and Shall be Deemed Renewed until Terminated for Consumable Supply with Fifty (50) Units Complimentary Free Use of Printers 4 in 1 Monochrome (ITB 14-017) is still undergoing review of technical specification and clarifications of other requirements thus the aforementioned project is indefinitely suspended until further notice.

    Thank you

     

     

  • Announcement

    For ITB 14-015

    Procurement of Supply, Delivery, Installation, Configuration Testing, Infrastructure (Hardware and Software) for One Hundred (100) VDI Users

    During the 2nd pre-bid conference, on 31 October 2014, 11AM at AFO Conference Room, FDA-Main Bldg., Alabang, Muntinlupa City, the FDA BAC will discuss with you the size of the monitor needed by the FDA end users.

    Read more...
  • Public Hearing on the New Guideline on Medical Device Registration

    Public Hearing on the New Guideline on Medical Device Registration

    TO : Medical Device Industries
    When : 3 November 2014, 9:00 am - 12:00 pm
    Public Hearing on the New Guidelines on Medical Device Registration
    Where : 3/F, AVR, Annex Building Food and Drug Administration,
    Alabang, Muntinlupa City

    For efficiency, participants shall register online through This email address is being protected from spambots. You need JavaScript enabled to view it. with the following prescribed format below:

    Email Subject  Public Hearing on the New Guideline on Medical Device Registration
    Body of Email
    Name of Participant : Last Name, First Name, MI.
    Company Name  
    Contact No(s)  
    Email Address  

    A confirmation slip will be sent as a reply, please bring a copy of your confirmation slip on the day of Public Consultation

    For your information, guidance, and compliance

  • Qualified Person in Industry Regulatory Affairs (QPIRA) Training to be Conducted by the Center for Cosmetic Regulation and Research (CCRR) and Center for Food Regulation and Research (CFRR) in Cebu 27-28 and 30-31 Davao City This October 2014

    Read more...
  • FDA Satellite Ofice - Ali Mall Cubao, Quezon City

    FDA Satellite Office - Ali Mall Cubao, Quezon City

    The Food and Drug Administration (FDA) Satellite Office in Ali Mall Cubao, Quezon City will start receiving applications for License to Operate (LTO), Certificate of Product Registration (CPR) and other authorizations following the Public Assistance, Information and Receiving (PAIR) procedure beginning 15 September 2014, Monday from 10am - 6pm. However, only those applications scheduled for the day with payment of appropriate fees and charges will be accepted. Applicant companies are further advised to submit product registrations for vaccines and biological at FDA Alabang.

    Submission of letter request and other communication such as ADRs/AEs, Clinical Trial Protocols and other related documents will be also received following the existence procedure.

    For your Information and Guidance.

Videos

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  • FDA Public Assistance Information and Receiving (PAIR) Video Tutorial

    A step by step guide to filing an application for a License to Operate or a Certificate of Product Registration.
    By: Nicole Melanie Molera

  • Dr. Kenneth Hartigan-Go on Responsible Pharmaceutical Manufacturing by Interphil

    Dr. Kenneth Hartigan-Go talks about importance of CGMP in manufacturing pharmaceutical products, bioequivalence, importance of adverse drug monitoring, and ethical marketing communications.

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