Cosmetic Products: How to Read the Label?
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.Read more...
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:
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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.Read more...
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.Read more...
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.
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.
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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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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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.
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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Ensuring Safe Medicines: How harmonization underpins international pharmacovigilance
Patient safety is one of the reason that health care is constantly innovating and evolving, but one unexpected and harmful consequence of medicinal use is adverse reactions. Product safety to help patient get well, and to manage optimally, or ideally avoid, illness is a collective responsibility of Industry, Drug regulators, and Clinicians and other healthcare professionals. There are many methods for undertaking and using Pharmacovigilance to protect the patients.