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FDA Guidance on Assessment of Drugs Abuse Potential

  • By: Staff Editor
  • Date: February 21, 2017
  • Source: https://www.fda.gov
Abstract:

FDA Guidance on Assessment of Drugs Abuse Potential

The abuse potential of a drug is a vital consideration in the development of a new drug. Physicians and healthcare providers need to know if the new drug is expected to be abused after approval and marketing to assure the protection of public health. Assessing drug abuse potential also provides the basis for controlling and regulatory actions related to drug control.

As a component of the safety evaluation of the new drug, FDA has recently finalized the guidance to aid investigational drug sponsors in assessing whether their new drug has abuse potential. According to this guidance, if the drug substance is CNS active and produce adverse effects such as hallucinations, the drug is likely to undergo detailed assessment of its abuse potential and is subjected to control under the Controlled Substances Act (CSA).

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