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Orange Book
(redirected from Approved Drug Products with Therapeutic Equivalence Evaluations)

   Also found in: Medical, Wikipedia 0.01 sec.
Orange Book
See NCSC and CD.
(security, standard)Orange Book - A standard from the US Government National Computer Security Council (an arm of the U.S. National Security Agency), "Trusted Computer System Evaluation Criteria, DOD standard 5200.28-STD, December 1985" which defines criteria for trusted computer products. There are four levels, A, B, C, and D. Each level adds more features and requirements.

D is a non-secure system.

C1 requires user log-on, but allows group ID.

C2 requires individual log-on with password and an audit mechanism. (Most Unix implementations are roughly C1, and can be upgraded to about C2 without excessive pain).

Levels B and A provide mandatory control. Access is based on standard Department of Defense clearances.

B1 requires DOD clearance levels.

B2 guarantees the path between the user and the security system and provides assurances that the system can be tested and clearances cannot be downgraded.

B3 requires that the system is characterised by a mathematical model that must be viable.

A1 requires a system characterized by a mathematical model that can be proven.

See also crayola books, book titles.


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to commercialize Intermezzo[R] in the United States, Transcept is eligible to receive one $10 million milestone payment from Purdue after either of the two formulation patents, once issued, is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
The '588 Patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations for Rythmol SR.
The new patents will expire in April 2023 and are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.
 
 
 
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