Description
This guidance is intended to assist sponsors of new drug applications (NDAs) with the development of drug products that treat or help prevent gingivitis in adults and children. This document defines gingivitis and clarifies the distinction between gingivitis and periodontitis. It discusses general issues such as over-the-counter (OTC) versus prescription status and prevention versus treatment. The bulk of this guidance focuses on trial design issues and clinical assessments. The document concludes with an examination of product safety determinations.
Scope & Applicability
Product Classes
4Products 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.
Nonprescription human drug products marketed without an approved application.
Guidance provides a framework for over-the-counter drug products.
Combination products and recognition as safe and effective
Stakeholders
2Entity responsible for submitting applications under section 524B
point of contact in the Division of Dermatologic and Dental Drug Products
Regulatory Context
Attributes
2Recommended trial length for chronic-use products
considered an adverse event if increased by topical dental drugs
Identified Hazards
Hazards
2adequately assess systemic toxicity
adverse event associated with some antigingivitis products
Related CFR Sections (4)
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
- 21CFR300.50§ 300.50 Fixed-combination prescription drugs for humans.
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:Read full regulation →
- 21CFR330.10§ 330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
For purposes of classifying over-the-counter (OTC) drugs as drugs generally recognized among qualified experts as safe and effective for use and as not misbranded drugs, the following regulations shall apply:Read full regulation →
See Also (8)
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (Status: Final)
- Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for Industry (Status: Final)
- PHS Guideline on Infectious Disease Issues in Xenotransplantation: PHS Guideline (Status: Final)
- Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry (Status: Draft)
- Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF) (Status: Final)
- How to Comply with the Pediatric Research Equity Act (Status: Draft)
- Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors (Status: Final)
- Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines: Guidance for Industry (Status: Final)