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Who needs the Assessment of Abuse Potential of Drugs Guidance for Industry?
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What are the instructions for submitting this form?
Submit the completed form via email to druginfo@fda.hhs.gov, fax to 301-431-6353, or mail to: Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg. 4th Floor, Silver Spring, MD 20993-0002. Ensure all required data is accurately entered.
What are the important dates for this form in 2024 and 2025?
Important dates for submission in 2024 and 2025 will be provided as updates become available.
What is the purpose of this form?
The purpose of this document is to guide the assessment of the abuse potential of drugs. It provides key decision points and recommended studies for evaluating abuse risk. Adherence to this guidance ensures the safety and regulatory compliance of new drug applications.
Tell me about this form and its components and fields line-by-line.
- 1. Introduction: Provides an overview of the guidance document.
- 2. Background: Explains the scope and definitions related to the document.
- 3. Assessing Abuse Potential: Outlines key decision points and recommended studies for evaluating drug abuse potential.
- 4. Chemistry and Nonclinical Studies: Includes data on drug chemistry, manufacturing, and nonclinical studies.
- 5. Human Studies: Provides abuse-related data from human clinical studies.
- 6. Post-Marketing Data: Includes data related to post-marketing and illicit drug abuse.
What happens if I fail to submit this form?
Failure to submit this form can result in significant delays or rejection of the drug application.
- Regulatory Non-Compliance: Non-compliance with regulatory requirements may lead to application rejection.
- Delayed Drug Approval: Delays in the review and approval process impacting market entry.
- Inaccurate Abuse Assessment: Failure to properly assess abuse potential may result in safety concerns.
How do I know when to use this form?
- 1. New Drug Application: Submitting a new drug for regulatory approval.
- 2. Abuse Potential Assessment: Conducting studies to evaluate the abuse potential of a drug.
- 3. Regulatory Compliance: Ensuring compliance with FDA guidance requirements.
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Who needs to use this document?
Pharmaceutical companies, regulatory bodies, researchers, healthcare professionals, and legal entities.
What is the purpose of this document?
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