Guidance For Industry - Assessment Of Abuse Potential Of Drugs - U.s. Department Of Health And Human Services - 2017 Page 14
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37Contains Nonbinding Recommendations
7. Its psychic or physiological dependence liability.
8. Whether the substance is an immediate precursor of a substance already controlled.
Following the medical and scientific analysis of abuse-related data submitted in the NDA, an
Eight Factor Analysis (8FA) document is drafted by CSS on behalf of the Secretary of HHS that
addresses the eight factors listed above. This 8FA takes into consideration the “description and
analysis of studies or information related to abuse of the drug, including a proposal for
scheduling under the Controlled Substances Act” submitted in the NDA in accordance with 21
CFR 314.50(d)(5)(vii), along with all relevant and available data. CSS and NIDA staff work
together with the goal of gaining concurrence on the 8FA and scheduling recommendations.
The 8FA is then provided to CDER’s Office of the Center Director at FDA, and finally to the
FDA Commissioner for review and comment. The finalized 8FA is transmitted from the Office
of the Commissioner at FDA to the ASH at HHS. NIDA may provide to the ASH/HHS the basis
for a separate recommendation. After the ASH/HHS considers the 8FA and recommendations,
the ASH/HHS transmits the final 8FA and scheduling recommendation to DEA.
After DEA receives the 8FA and recommendations, DEA may respond by issuing a notice of
proposed rulemaking, an interim final rule, or final rule on the HHS scheduling recommendation
in the Federal Register. After allowing time for public comment, DEA generally responds with a
scheduling order or respond to issues raised by the public. The final rule may respond to any
comments received from the public, and confirms a scheduling placement for the drug and the
effective date (see generally 21 U.S.C. 811, 21 CFR 1308.43).
With the enactment of the Improving Regulatory Transparency for New Medical Therapies Act
in 2015, FDA approval of a new drug may not take effect until DEA issuance of an interim final
rule under 21 U.S.C. 811(j) establishing schedule placement for the drug, in accordance with 21
U.S.C. 355(x). See Pub. L. No. 114-89, 129 Stat. 698 (Nov. 25, 2015).
Once DEA has issued a final scheduling decision and assigned a controlled substance schedule,
the controlled substance symbol, e.g., C-II, C-III, C-IV or C-V, must be included in the product
labeling as required under 21 CFR 201.57(c)(10)(i) and 1302.03. In order to update the labeling
following the scheduling action, a supplement to the NDA must be submitted by the applicant to
update product labeling to reflect the DEA scheduling action described in the final rule or
interim final rule. See 21 CFR 314.70. The appropriately labeled FDA-approved drug product
may then be marketed.
IV.
ABUSE-RELATED DATA FROM CHEMISTRY AND NONCLINICAL STUDIES
Abuse-related data can be obtained from a variety of chemistry studies and nonclinical
studies, including those that investigate pharmacology, pharmacokinetics, general animal
behavioral effects, self-administration, drug discrimination, and physical dependence in
animals.
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