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  2. Food and Drug Administration Safety and Innovation Act

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

    The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.

  3. History of the Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/History_of_the_Food_and...

    In the mid-1970s, 13 of the 14 drugs the FDA saw as most important to approve were on the market in other countries before the United States. [13] As part of the U.S. Public Health Service reorganizations of 1966–1973, FDA became part of the Public Health Service (PHS) within the Department of Health, Education, and Welfare in 1968. It was ...

  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. National drug code - Wikipedia

    en.wikipedia.org/wiki/National_Drug_Code

    The national drug code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 [ 1 ] [ 2 ] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed ...

  6. Food and Drug Administration Amendments Act of 2007

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

    It sets forth special rules for positron emission tomography drugs, including subjecting an applicant in a drug application for a PET drug to one-sixth of the annual prescription drug establishment fee. It exempts approved drugs or biological products designated for a rare disease (orphan drugs) from product and establishment fees if certain ...

  7. Medical Device User Fee and Modernization Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_User_Fee...

    FDA Amendments Act of 2007: Added two types of annual fees: establishment registration fee and product fee 2012: MDUFA III: Safety and Innovation Act of 2012: Expanded the definition of establishments subject to a registration fee, thus increasing the applicable device establishments paying the fee. 2017: MDUFA IV: FDA Reauthorization Act of 2017

  8. 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).

  9. Prescription Drug User Fee Act - Wikipedia

    en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act

    Prescription Drug User Fee Act; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to authorize human drug application, prescription drug establishment, and prescription drug product fees and for other purposes. Acronyms (colloquial) PDUFA, DSA: Nicknames: Dietary Supplement Act of 1992: Enacted by: the 102nd United States ...