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...
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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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.
In line with the strengthening of the FDA's capability on licensing of all regulated establishments, a new harmonized license to operate format shall be used and issued by this Office effective 15th day of January 2014.
The new LTO format shall reflect only the pertinent information of the said establishments. Other information such as the names of the key personnel (pharmacist, production head, quality control and quality assurance manager and authorized person to release the batch) shall be shown in the LTO attachment or certification in case of amendments.
For those establishments capable of handling vaccines, biologics and other temperature-sensitive drug products, a clause stating the same shall also be reflected in compliance with the Cold Chain Management Requirement circular (BC 2007-003).
For your guidance.
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The public consultation on the draft Administrative Order, Rules and Regulations on the Licensing of Drug Establishments and Other Related Authorizations Further Amending for this Purpose Administrative Order No. 56 s.1989 on the "Revised Regulations for the Licensing of Drug Establishments and Outlets," and for other Purposes is rescheduled on February 3, 2014 (Monday) at 9:30 A.M. The activity will still be held at the 3rd Floor AVR, FDA Annex Bldg., FDA Compound, Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City.
For your information, guidance, and compliance.
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Please be informed that the Center for Drug Regulation and Research is extending the deadline for the submission of electronic copy of all registered drug products, pursuant to FDA Memorandum Circular No. 2013-023, from 30 September 2013 to 30 June 2014.
Submission requirements shall still follow Sec. 4, item 4.1 of FDA Memorandum Circular No. 2013-023. However, instead of using the DVD, a USB shall be used. The device will be returned to the Market Authorization Holder (MAH) once the dossier has been copied by FDA. Please take note that all data for the latest life cycle of a product must be submitted, i.e., for products existing for 12 years in the market, the 2nd renewal documents shall be submitted including any other documents (e.g. amendments, variations) submitted during its validity; for products existing for 4 years, the initial application documents shall be submitted including any other documents submitted during its validity. Please take note of the following documentary requirements for initial and renewal applications:
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