FDA BRIEF: Week of January 16, 2017fda guidances


abuse

Abuse Potential assessment of CNS active drugs

  • Under Controlled Substances Act (CSA) : Schedules I, II, III, IV and V (I being most controlled)
  • Placement determined on relative abuse potential and psychological or physical dependence
  • FDA along with DEA (Control Substances Staff) and NIDA involved in review that includes preparation of 8 Factor Analysis (8FA)

OVERVIEW

Assessing Abuse Potential

  • Key Decision Points and Recommended Studies
  • When Abuse-Related Studies Should Be Conducted
  • Preparing NDA Submission
  • NDA Review and Product Labeling Related to Abuse Potentia
  • Drug Scheduling Process.

Abuse-Related Data  form Chemistry and Nonclinical Studies

  • Chemistry and Manufacturing
  • Screening with Receptor-Ligand Binding Studies
  • Use of Nonclinical Pharmacokinetic Data in Animal Abuse-Related Studies
  • Animal Abuse-Related Behavioral Pharmacology Studies

Abuse-Related Data from Clinical Studies

  • Use of Clinical Pharmacokinetic Data in Human Abuse-Related Studies
  • Abuse-Related Adverse Events in Clinical Safety and Efficacy Studies.
  • Human Abuse Potential Study in Recreational Drug Users
  • Clinical Studies That Evaluate Cognition and Performance
  • Clinical Evaluation of Physical Dependence

Post-Marketing Illicit Drug Abuse data

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final rule.JPG

Final rule on Protection of Human Subjects enhances protections for research participants, modernizes oversight system

IMPORTANT ELEMENTS

  • Informed Consent to provide better understanding of scope, risks and benefits
  • Use single institutional review board (IRB) for multi-institutional research studies
  • For studies on stored identifiable data or identifiable biospecimens, alternative to seek Consent waiver
  • New exempt categories of research based on risk level
  • Consent for certain federally funded clinical trials be posted on public website

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