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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

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