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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. Peter Marks (physician) - Wikipedia

    en.wikipedia.org/wiki/Peter_Marks_(physician)

    Yale University. Doctoral advisor. Frederick R. Maxfield. Peter Marks is an American hematologist oncologist serving as the director of the Center for Biologics Evaluation and Research within the Food and Drug Administration. He was appointed to the position in 2016 after previously serving as deputy director.

  4. Center for Biologics Evaluation and Research - Wikipedia

    en.wikipedia.org/wiki/Center_for_Biologics...

    The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of ...

  5. Philippine Drug Enforcement Agency - Wikipedia

    en.wikipedia.org/wiki/Philippine_Drug...

    The Philippine Drug Enforcement Agency (PDEA, / piːˈdeɪə /; [1] Filipino: Ahensiya ng Pilipinas sa Pagpapatupad ng Batas Laban sa Bawal na Gamot[2]) is the lead anti-drug law enforcement agency, responsible for preventing, investigating and combating any dangerous drugs, controlled precursors and essential chemicals within the Philippines ...

  6. Biologics license application - Wikipedia

    en.wikipedia.org/wiki/Biologics_License_Application

    The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility ...

  7. The breakthrough devices program at the FDA is a voluntary program that developers can apply to that, if granted, “offers manufacturers an opportunity to interact with FDA experts through ...

  8. Center for Drug Evaluation and Research - Wikipedia

    en.wikipedia.org/wiki/Center_for_Drug_Evaluation...

    The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research.

  9. PDUFA date - Wikipedia

    en.wikipedia.org/wiki/PDUFA_date

    PDUFA date. In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. [1] It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and ...

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