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In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
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 ...
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 ...
In business, an MoU is typically a legally non-binding agreement between two (or more) parties, outlining terms and details of a mutual understanding or agreement, noting each party's requirements and responsibilities—but without establishing a formal, legally enforceable contract (though an MoU is often a first step towards the development of a formal contract).
The National Security Agency (NSA) is an intelligence agency of the United States Department of Defense, under the authority of the Director of National Intelligence (DNI). The NSA is responsible for global monitoring, collection, and processing of information and data for foreign intelligence and counterintelligence purposes, specializing in a ...
COB – Close of Business. COC – Cost of Credit [2] or Cost of Capital [3] COD – Cost of Debt [4] or Cash on Delivery. COE – Center of Excellence or Cost of Equity [5] COGS – Cost of Goods Sold. Corp. – Corporation. COO – Chief Operating Officer. CPA – Certified Public Accountant. CPI – Consumer Price Index.
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