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FDA to review all new CNS drugs for abuse potential.(Food and Drug Administration, central nervous system)

Alcoholism & Drug Abuse Weekly

| February 15, 2010 | (Hide copyright information)Copyright

The Food and Drug Administration (FDA) is issuing draft guidelines for drug makers to follow in determining whether their products have abuse potential. Published in the Jan. 27 Federal Register, the guidelines discuss how abuse potential is defined, what information to submit to the FDA on abuse potential and how to conduct an abuse potential assessment, and information on the design and conduct of studies.

The Drug Enforcement Administration (DEA) considers a drug's abuse potential in determining what "schedule" it belongs on. The most restrictive, Schedule I, is for illegal drugs with high abuse potential, such as heroin. Schedule II is the most restrictive category of …

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