Description
The purpose of this guidance is to outline the FDA’s current thinking on the principles of clinical development relevant to dose-selection and assessment of efficacy and safety to support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It also addresses additional considerations for drug products developed as drug-device combination products. This guidance does not address nonclinical development, development of drug products for juvenile idiopathic arthritis, or development of biosimilar products.
Scope & Applicability
Product Classes
4Recommendations for the Use of Biologic Agents in the Treatment of Rheumatoid Arthritis
Recommendations for the Use of Disease-Modifying Antirheumatic Drugs
A product category excluded from the scope of this guidance.
Products 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.
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
1The basis for recommending doses and dosing regimens.
Identified Hazards
Hazards
3A serious adverse event of interest in RA drug development.
Serious dose-related adverse reactions associated with RA drug products.; A long-term safety concern for RA treatments.
Serious dose-related adverse reactions associated with RA drug products.
Related CFR Sections (1)
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
Related Warning Letters (4)
- 2025-03-18
CGMP/Finished Pharmaceutical/Adulterated
Advanced Pharmaceutical Technology
- 2024-08-27
CGMP/Drugs/Adulterated
EyePoint Pharmaceuticals, Inc.
- 2024-08-06
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Omega Tech Labs LLC
- 2021-06-29
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Aquavit Pharmaceuticals, Inc
See Also (8)
- Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (Status: Final)
- Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry: Guidance for Industry (Status: Final)
- Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (Status: Draft)
- ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (Status: Draft)
- Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations (Status: Draft)
- Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration Staff (Status: Final)