Search results
Results from the WOW.Com Content Network
The Food and Drug Administration (FDA) of the Philippines, formerly the Bureau of Food and Drugs (BFAD / ˈ b iː f æ d /; 1982–2009), is a health regulatory agency under the Department of Health created on 1963 by Republic Act No. 3720, amended on 1987 by Executive Order 175 otherwise known as the "Food, Drugs and Devices, and Cosmetics Act", and subsequently reorganized by Republic Act No ...
[1] [better source needed] It is similar in function, in many respects, to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Spanish Agency of Medicines and Medical Devices in Spain or the Food and Drug Administration in the Philippines. [2]
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
Ten years later, with the beginning of the biotechnology revolution, the line between a drug and a biologic, or a device and a biologic, became blurred. [8] It was merged with the FDA's Bureau of Drugs to form the Center for Drugs and Biologics during an agency-wide reorganization under Commissioner Arthur Hayes. [8]
Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).