FDA BRIEF: Week of January 16, 2017
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
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