Description
This guidance provides sponsors with recommendations on the nonclinical information to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications.
Scope & Applicability
Product Classes
3Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Subject to the deeming rule, including e-cigarettes and vape pens
primary product category covered by the guidance
Stakeholders
2Entity responsible for submitting applications under section 524B
Assist sponsors in the nonclinical evaluation
Regulatory Context
Attributes
1measured by systemic availability of pharmaceutical-related substances
Identified Hazards
Hazards
3novel chemicals generated from any chemical of the drug product formulation by the delivery system
adequately assess systemic toxicity
chemicals created by the delivery system from formulation
Related CFR Sections (2)
- 21CFR1100.5§ 1100.5 Exclusion from tobacco regulation.
If a product made or derived from tobacco that is intended for human consumption is intended for use for any of the purposes described in paragraph (a) or (b) of this section, the product is not a tobacco product as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act and will be sRead full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →