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SAFETY
ALERTS US
FDA AND HEALTH CANADA HAS ISSUED THE
FOLLOWING UPDATES
FOR YOUR INFORMATION Revlimid
(lenalidomide)
- Association with an Increased Risk of Second Cancers -
Celgene
Inc. Fentanyl
Patch Can Be Deadly to Children FDA Drug Safety Communication: New
Warning and Contraindication for blood pressure medicines containing
aliskiren FDA Drug Safety Communication: Safety
review of
post-market reports of serious bleeding events with the anticoagulant
Pradaxa
(dabigatranetexilatemesylate) |
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| REGISTERED PRODUCTS | ||||||||||
DRUG                            COSMETIC PRODUCT NOTIFICATION  |
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| 2012 NEW DRUG APPLICATION | ANNOUNCEMENT | DRAFT FOR COMMENTS | ||||||||
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To: ALL FDA CLIENTS AND THE GENERAL PUBLIC | Draft Joint Administrative Order between the Department of Agriculture and the | ||||||||
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The Food and Drug Administration will have its annual team building |
Department of Health on the Regulations of Veterinary Drug
Products 
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activity on 28-29 May 2012 at FDA Alabang, Muntinlupa City. |
This
Joint AO is for public consultation on 23 March 2012, to be held at the
3rd floor, FDA Annex |
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Relative thereto, operations of the agency will be temporarily suspended | Building, Alabang, Muntinlupa City at 10:00 AM. Those who are interested to attend the | ||||||||
| and shall resume on 30 May 2012. |
consultation are welcome. | |||||||||
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| FDA LOCATION | Adverse Events Following Immunization (AEFI) Training on May 28-June 1 for | Proposed Revisions of Bureau Circular No. 01A-2004 entitled Guidelines for the | ||||||||
 |
Luzon Area-DOH Hospitals - POSTPONED |
Assessment
of Microbiological Quality of Processed Foods. |
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| We will appreciate receiving your comments and suggestions on or before 20 April 2012. | ||||||||||
| The Saudi Food and Drug Authority launched its electronic services to facilitate and | Please provide your suggested texts including your reasons and data to support your | |||||||||
| expedite procedures in the entry of imported foods in to Saudi Arabia. Part of the | comments and send these through email at acdavid_fda@yahoo.com and elanevm@yahoo.com | |||||||||
| services
is to expedite processing and registration and certification of the
exporters of slaughterhouses and manufacturing of meat, poultry and fish products for export to the Kingdom of Saudi Arabia. The said electronic services is accessible at www.sfda.gov.sa/En/Food/E-Service.htm. To : All Household/Urban Hazardous Substances Establishments |
or fax at telephone nos.
(02) 8070751 / 8425606 Draft Standard for Salt Fermented Fish and Shrimps, and other Shellfish (Bagoong) Draft Recommended Code of Practice for the Processing and Handling of Salt Fermented Fish and Shrimps, and other Shellfish (Bagoong) |
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| and Other
Concerned Stakeholders |
Your comments and suggestions will be appreciated on or before 17 April 2012 at the following: | |||||||||
| Subject: Review of
Existing Rules and Regulations Covering Household/Urban Hazardous Substances Pursuant to the issuance of the Implementing Rules and Regulations of 2011 of the Republic Act 9711, the Strengthening Act of the Food and Drug Administration of 2009, the FDA will |
Email
address: elanevm@yahoo.com, charimay@lycos.com,
charimay@mailcity.com or FDA-PPAD telefax: 842-56-06 |
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| be reviewing the existing rules and regulations on
Household/Urban Hazardous Substances covering
licensing of
establishments in the areas of manufacturing/repacking/packing and
distribution/importation/exportation; Household/Urban
Hazardous
Substances operators; and product registration for
possible amendments. In this regard, all concerned are enjoined to submit before the Policy, Planning and |
Implementing
Guidelines of Administrative Order No. 2010-0012 declaring
the "Policy Requiring the Temporary Suspension of Acceptance by the Food and Drug Administration of Initial Applications for Drug Product Registration and Criteria for One Hundred (100) Registered Formulations."
|
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| Advocacy Division of the FDA their respective propose admendments
for consideration.
The FDA will start accepting proposals by
01 February 2012 until
31
March 2012. |
Adoption and
Implementation of
the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guides for the Good Manufacturing Practice (GMP) for Medicinal Products (Draft A.O.)
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| Guidelines
for GMP
Clearances and Inspection of Foreign Drug
Manufacturers (Draft A.O) |
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