Latest Advisories

  • FDA Advisory No. 2015-019 || Public Warning Against the Use of the following Unregistered Drug Products

  • FDA Advisory No. 2015-019-A || Babala sa Publiko Tungkol sa Paggamit ng mga Sumusunod na Hindi Rehistradong Gamot

  • FDA Advisory No. 2015-018 || Termination of Product of Recall order issued on Specific Batches of Dobutamine (as Hydrochloride) 12.5 mg/mL (250 mg/20 mL) Solution for Injection (Dobulon)

     

  • FDA Advisory No. 2015-017 || Termination of Product Recall order issued on Specific Batches of 8.4% Sodium Bicarbonate Solution for IV Infusion

     

  • FDA Advisory No. 2015-016 || Termination of Product Recall order issued on Specific Batches of Paroxotine (Seroxat) 20 mg Tablet

Announcement

  • Second Meeting on the Regulation of Finished Paint Products

    ANNOUNCEMENT

    To      : All Concerned Paint Stakeholders

    From    : Center for Cosmetics Regulation and Research (CCRR)

    Subject : Second Meeting on the Regulation of Finished Paint Products

    In the Interest of service, the Center for Cosmetics Regulation and Research (CCRR) shall conduct a second meeting on the regulation of finished paint products to further discuss regulatory measures involving household/urban hazardous substances (HUHS), particularly paint products, with the following details:

    Date : 27 March 2015
    Time : 1:00 PM
    Venue : CDRRHR (Formerly BHDT) Conference Room
               Building 24, Department of Health
               San Lazaro Compound, Rizal Avenue, Sta. Cruz, Manila

    All concerned paint stakeholders are invited to attend. Registration by e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it. is on a first-come, first-serve basis and only twenty (20) participants (one representative per company) will be accommodated for this activity

    For your information and guidance.

  • Request for Rescheduling of Appointment/Submission

    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

  • National Consultation for Adoptation and Implementation of the Association of Southeast Asian Nations (ASEAN) Traditional Medicines and Health Supplements (TMHS) Guidelines for Davao

    Due to flight availability, the national consultation to discuss the upcoming adoptation and implementation of the Association of Southeast Asian Nations (ASEAN) Traditional Medicines and Health Supplements (TMHS) Guidelines for Davao on 18 March 2015 is rescheduled from 9:00 AM to 12:00 NN to 1:00 PM - 4:00 PM.

    For more information kindly coordinate with Regional Filed Office XI

    For your information, guidance, and compliance

  • Scheduled Delay in Processing of Electronic Cosmetic Product Notification

    ANNOUNCEMENT

    TO : All Cosmetics Manufacturer, Traders, Distributors and other concerned parties
    DATE : 19 November 2014
    SUBJECT : Scheduled Delay in Processing of Electronic Cosmetic Product Notification
                                         (Cosmetic e-Notification)
  • QPIRA ID for Release

    ANNOUNCEMENT

    DATE        : 10 November 2014
    TO            : ALL REGISTERED QUALIFIED PERSON IN
    INDUSTRY REGULATORY AFFAIRS (QPIRA)
    FROM        :  ATTY. RONALD R. DE VEYRA, MBA, CESO VI
     Acting Deputy Director General - AFO
    SUBJECT   : QPIRA ID for Release

Videos

  • Win the War Against AMR

    The misuse of antibiotics is creating resistant "superbugs" that may leave you or your family without effective treatment the next time antibiotics are needed.

  • 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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