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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. National Medical Products Administration - Wikipedia

    en.wikipedia.org/wiki/National_Medical_Products...

    The National Medical Products Administration is directly under the State Council of the People's Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China. [6]

  4. National drug code - Wikipedia

    en.wikipedia.org/wiki/National_Drug_Code

    The national drug code is a unique 10 or 11 digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment, the labeler code, is ...

  5. Biologics license application - Wikipedia

    en.wikipedia.org/wiki/Biologics_License_Application

    A biologics license application ( BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: 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.

  6. Marketing authorisation - Wikipedia

    en.wikipedia.org/wiki/Marketing_authorisation

    Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority ...

  7. Halal certification in the Philippines - Wikipedia

    en.wikipedia.org/wiki/Halal_certification_in_the...

    Halal Act of 2016. There is national legislation mandating the government to regulate the halal certification of goods in the Philippines and promote halal-certified goods for export. This legislation is known as the Philippine Halal Export Development and Promotion Program Act of 2016 (Republic Act 10817). The law took effect on July 26, 2017 ...

  8. 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 ...

  9. Approved drug - Wikipedia

    en.wikipedia.org/wiki/Approved_drug

    A fee is required to make such FDA submission. For financial year 2020, this fee was: for an application requiring clinical data ($2,942,965) and for an application not requiring clinical data ($1,471,483). [4] A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling.