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  2. Food and Drug Administration (Philippines) - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug...

    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 ...

  3. Fast track (FDA) - Wikipedia

    en.wikipedia.org/wiki/Fast_track_(FDA)

    NDA review usually does not begin until the drug company has submitted the entire application to the FDA; An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently ...

  4. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    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 ...

  5. Center for Food Safety and Applied Nutrition - Wikipedia

    en.wikipedia.org/wiki/Center_for_Food_Safety_and...

    The Center for Food Safety and Applied Nutrition (CFSAN (/ ˈ s ɪ f ˌ s æ n / SIF-san)) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA.

  6. Pharmaceuticals and Medical Devices Agency - Wikipedia

    en.wikipedia.org/wiki/Pharmaceuticals_and...

    It is similar in function 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] The PhMDA has been eCTD compliant at least since December 2017 ...

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  8. Marketing Authorisation Application - Wikipedia

    en.wikipedia.org/wiki/Marketing_authorisation...

    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.

  9. MedWatch - Wikipedia

    en.wikipedia.org/wiki/MedWatch

    Reporting can be conducted online, [3] by phone, or by submitting the MedWatch 3500 form by mail or fax. In 2013, MedWatch introduced Form 3500B, which is designed to facilitate reporting by healthcare consumers. [4] The MedWatch system is intended to detect safety hazard signals for medical products.

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