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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.
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
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: Advanced the use of real-world evidence and patient engagement 2022: MDUFA V
The law abolishes the long-standing prohibition of broadcasting by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to circulate peer-reviewed journal articles about an off-label indication of its product, providing the company is also committing itself to file proof of research within a ...
The National Banking Act of February 25, 1863, Sess. 3, ch. 58, was the 58th Act of the third session of the 37th Congress. The Global Anti-Semitism Review Act of 2004 of October 16, 2004, Pub. L. 108–332 (text) (PDF) , 118 Stat. 1282 , was the 332nd Act of Congress (statute) passed in the 108th Congress.
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs.In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. [1]
Any chemical substance with biological activity may be considered a drug. This list categorises drugs alphabetically and also by other categorisations. This multi-page article lists pharmaceutical drugs alphabetically by name. Many drugs have more than one name and, therefore, the same drug may be listed more than once.
The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug or other substances may lead to severe psychological or physical dependence. The complete list of Schedule II substances is as follows.