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FDA Advisories

  • FDA Advisory No. 2014-030

    Consumer Information on Over Exposure Under the Sun and the Use of Sunscreen Products

    Over exposure to ultraviolet (UV) rays from the sun may lead to skin cancer. There are two harmful UV rays. The UV-A rays which easily pass through glass windows and cause wrinkles and pre-mature aging of the skin, and the UV-B rays which are blocked by glass windows and cause sunburn. Water reflects the damaging rays of the sun and increases the chance of sunburn.

    There are practical ways to avoid over exposure from harmful sun rays. Protective clothing may be worn, such as the use of long-sleeved shirt, pants, a hat or sunglasses. The sun's rays are most intense between 10 am and 3 pm. In order to protect the skin from over exposure to damaging UV rays, always seek shade or use an umbrella.

    If staying under the sun is unavoidable, use sunscreen protection, which comes in different preparation, like lotion, cream, gel, or ointment, are available. Creams are best for the face and dry skin. Gels are good for hairy areas of the skin. Water resistant sunscreen products are best when going swimming or when sweating profusely. Regardless of which sunscreen preparation you choose, be sure to apply it generously to achieve full UV ray protection.

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  • FDA Advisory No. 2014-020

    PRODUCT RECALL OF BATCH SPECIFIC CEFUROXIME 750 mg POWDER FOR INJECTION

    The public is hereby warned by the Food and Drug Administration (FDA)  that the following Cefuroxime 750 mg Powder for Injection products with batch number 9600, manufactured by Flamingo Pharmaceuticals Ltd.-India and imported by Pasteur Pharmaceuticals Sales is being recalled from the market:

    Registration NumberBrand Name
    DRP-282 Zurenix
    DRP-282-02 Eurimax
    DRP-282-03 Cefunor
    DRP-954 Zurenix WFI
    DRP-954-01 Baktime WFI
    DRP-954-02 Hiquacef
    DRP-954-03 Cervin
    DRP-954-04 Cefura
    DRP-954-05 Rezafil WFI
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  • FDA Advisory No. 2014-029

    Public Health Warning Against the Use of Unregistered CMD Eye Drop

    The Food and Drug Administration advises the public against the use of an unregistered product, CMD Eye Drop. The product which was labeled to he "best for astigmatism, cataracts, pterygium, glaucoma, sore eyes, eye stress, red and itchy eyes, blurry 'computer' vision and more" was found to he sold in Metro Manila at Php 120.00 per 15 mL bottle and is allegedly sold by refill in some outlets in the province.

    The product was also labeled as "BFAD Registered" with Registration No. FR-98502. However, upon verification of the sample's authenticity, it was confirmed to be unregistered.

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  • FDA Advisory No. 2014-028

    Babala sa Publiko Tungkol sa Paggamit ng Hindi Rehistradong "CMD Eye Drop"

    Pinapayuhan ng Food and Drug Administration ang publiko laban sa paggamit ng hindi rehistradong produkto na CMD Eye Drop. Nakasaad sa label ng produkto na maaaring gamitin sa "astigmatism, cataracts, pterygium, glaucoma, sore eyes, eye stress, red and itchy eyes, blurry 'computer' vision and more." Nakasaad din na ito ay "BFAD registered" at may "Registration No. FR-98502."

    Napag-alamang binebenta ang nasabing produkto sa Metro Manila sa halagang Php 120.00 kada 15mL. Napag-alaman din na sa mga lalawigan, ang produktong ito ay isinasalin sa nagamit ng mga lalagyan.

    Hindi po rehistrado ng FDA ang CMD Eye Drop.

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  • FDA Advisory No. 2014-027

    PUBLIC HEALTH WARNING AGAINST UNREGISTERED COOKING OIL AND SUGAR PRODUCTS REPACKED AND DISTRIBUTED BY AUTHORITY TRADING CORP.

    In view of the report and findings of the Food and Drug Administration, the public is hereby warned on the following cooking oil and sugar products being repacked and distributed by Authority Trading Corp. (ATC) in Valenzuela City:

    • Lucky Light Washed Sugar, ¼kg.
    • Lucky Light Refined Sugar, ¼ kg.
    • Luck Light Refined Sugar, ½ kg.
    • Best Quality Puregold Equal Refined Sugar, ¼ kg.
    • Best Quality Puregold Equal Refined Sugar, 1 kg.
    • 5 Pinya Raw Sugar, ¼ kg.
    • 5 Pinya Raw Sugar, ½ kg.
    • Jumbo Savings Pure Cooking Oil, 314 grams
    • ATC Lucky Light Cooking Oil
    • ATC Aflower Light Cooking Oil
    • Daylee Pure Vegetable Cooking Oil
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Administrative Order 2014-0016

Adoption of the World Health Organization "Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)" for the Registration of Biosimilar Products"

I. Rationale

Republic Act No. 3720, otherwise known as the "Foods, Drugs and Devices, and Cosmetic Act" as amended, and Republic Act No. 9711, otherwise known as the "Food and Drug Administration Act of 2009", and its Implementing Rules and Regulations, declare that it is the policy of the state to insure the safety, efficacy and quality of drug supply in the country so as to protect the health of the Filipino people.

Biological medicinal products, or biologics, are drug products derived from living organisms.  Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins.

Similar Biotherapeutic Products (SBPs) or biosimilars, on the other hand are new biological medicinal products claimed to be similar to an already approved Reference Biotherapeutic Product (RBP).  However, based on the current analytical techniques, due to the complexity of their structures, SBPs made by different manufacturers using different processes cannot be shown to be identical, rather similar at best, wit the RBP.   Unlike the chemically derived medicinal products, which have smaller and simpler molecular structures, the usual generic approach is not applicable for the evaluation of similar biologic products.  Thus, the need for an effective regulatory approach on the registration of similar biological product has increased.

 

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FDA Philippines Hosts the Drug Regulatory Study Tour of Legislators from the Parliament of Mongolia and Senior Staff of the Ministry of Health of Mongolia

FDA Philippines hosted the study tour of delegates from Mongolia, consisting of five Members of Parliament and four senior officialsof the Ministry of Health (MOH) on 01-04 April 2014. The study tour aimedto give first-hand exposure on how the Philippines established its Food and Drug Administration, how it set up its organization and management system, and how it developed its regulatory and enforcement system. The visit was intended to help the Mongolian legislators in their planned revision of their Mongolian Medicines Law.

FDA Order No. 2014-003

PRESCRIBING THE PROCEDURE FOR THE RECEIVING AND FURTHER ACTION BY ALL CENTERS AND OFFICES OF THE FOOD AND DRUG ADMINISTRATION (FDA) OF ALL APPLICATIONS FOR LICENSE TO OPERATE FILED BY ESTABLISHMENTS WITHIN THE NATIONAL CAPITAL REGION

I. RATIONALE

     Republic Act No. 9711 or the Food and Drug Act of 2009 seeks to enhance the Food and Drug Administration's administrative and technical capacity and strengthen its capability with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products.

     Hence, it becomes incumbent upon t he agency to endeavor to find ways to adopt and maintain an effective health product regulatory system.  Thus, this directive is promulgated to prescribe the processes relating to the receiving and further action by the concerned Centers and Offices in the FDA pertaining to applications for license to operate of establishments under its jurisdiction.

II.  OBJECTIVES

     This Order is issued to contribute to the improvement of the agency's efficiency and productivity in the performance of its regulatory function consistent with the expressed objectives of the FDA Act of 2009 to ensure the FDA's monitoring and regulatory coverage over establishments and products; and to provide coherence in the FDA's regulatory system for establishments and products under its jurisdiction.

 

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FDA Circular No. 2014-009

Filing and Submission of Applications for the Approval of Clinical Trial Protocol, Compassionate Special Permit (CSP), Import Permit for Investigational Drug Products, Pharmacovigilance, Adverse Events/Adverse Reaction Reports, and Other Related Documents

I. Rationale

Republic Act 9711 otherwise known as the Food and Drug Act of 2009 empowers the FDA to develop and issue policies, guidelines and regulations that cover establishments,facilities and health products.

Under Republic Act 9485 or the Anti-Red Tape Act of 2007, all government agencies and offices providing frontline services are mandated to regularly undergo evaluation and improvement of their transaction systems and procedures.

II. Objectives

In consonance with the regulatory reforms implemented by the FDA to improve efficiency and quality of services rendered, this guidelines is issued to prescribe/establish the procedure in filing and submission of applications for Clinical Trial Protocol approval, Compassionate Special Permit, Import Permit for Investigational Drug Products and other related documents.  Adoption and implementation of this guidelines seek to provide a simplified, transparent and convenient procedure to all concerned industry partners.

 

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FDA Memorandum Circular No. 2014-005

Updated List of Medical Devices Required to be Registered Prior to Sale, Distribution and Use

In pursuit of attaining systematic regulation of medical devices, including in-vitro diagnostic medical devices, the Center of Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration, Department of Health is providing updated list of medical devices and in-vitro diagnostic medical devices that are required for mandatory registration pending the implementation of the full regulation of all medical devices.

The list is based on the BFAD Memorandum No. 7 s. 1992 that identifies the list of registrable medical devices and from the consolidated database of registered medical devices.

 

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