Orange Book

(redirected from Approved Drug Products with Therapeutic Equivalence Evaluations)
Also found in: Medical.

Orange Book

(security, standard)
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.
References in periodicals archive ?
patents listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book.
The three newly issued patents will be listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange-Book) bringing Eagle's total Orange Book listed patents for Bendeka to thirteen.
According to the company, the '498 patent is listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the US Food and Drug Administration.
The '588 Patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations for Rythmol SR.
The company's new patent 8,324,275, awarded by the US Patent and Trademark Office, will be submitted for listing in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book).
All of the currently issued patents are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book.

Full browser ?