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An Abbreviated New Drug Application ( ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug . The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
Legal release. A legal release is a legal instrument that acts to terminate any legal liability between the releasor and the releasee (s), signed by the releasor. A release may also be made orally in some circumstances. Releases are routinely used by photographers, in film production, by documentary filmmakers, or by radio and music producers ...
A generic drug (or simply generic) is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in ...
A release of information (ROI) department or division is found in the majority of hospitals. In the United States, HIPAA and state guidelines strongly direct the rules and regulations of patient information. ROI departments perform such tasks as obtaining patient consent, certifying medical records, and deciding what information can be released ...
Standard Form 312 (SF 312) is a non-disclosure agreement required under Executive Order 13292 to be signed by employees of the U.S. Federal Government or one of its contractors when they are granted a security clearance for access to classified information. The form is issued by the Information Security Oversight Office of the National Archives ...
The Freedom of Information Act (FOIA / ˈ f ɔɪ j ə / FOY-yə), 5 U.S.C. § 552, is the United States federal freedom of information law that requires the full or partial disclosure of previously unreleased or uncirculated information and documents controlled by the U.S. government upon request. The act defines agency records subject to ...