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A unilateral NDA (sometimes referred to as a one-way NDA) involves two parties where only one party (i.e., the disclosing party) anticipates disclosing certain information to the other party (i.e., the receiving party) and requires that the information be protected from further disclosure for some reason (e.g., maintaining the secrecy necessary to satisfy patent laws [5] or legal protection ...
New Drug Application. The Food and Drug Administration 's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. [1][2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug ...
The National Defense Authorization Act (NDAA) is any of a series of United States federal laws specifying the annual budget and expenditures of the U.S. Department of Defense. The first NDAA was passed in 1961. [1][2] The U.S. Congress oversees the defense budget primarily through two yearly bills: the National Defense Authorization Act and ...
Angelina Jolie has been ordered to hand over years worth of non-disclosure agreements (NDAs) amid her ongoing battle with ex-husband Brad Pitt over the winery they co-owned. On Thursday, May 16, a ...
Signed into law by President George H. W. Bush on October 29, 1992. The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to ...
A person is granted access to a specific compartment after the individual has: (a) had a Single Scope Background Investigation similar to that required for a collateral Top Secret clearance; (b) been "read into" or briefed on the nature and sensitivity of the compartment; and (c) signed a non-disclosure agreement (NDA). Access does not extend ...
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