Description
This guidance is intended to assist developers of drugs, biological products, and medical devices intended for the treatment of rheumatoid arthritis (RA). The document discusses the types of label claims that can be considered for such products and provides guidance on the clinical development programs to support those claims.
Scope & Applicability
Product Classes
10Clinical investigations of drugs, including human drugs and biological products
Assessment of embryo-fetal developmental toxicity; Small molecules, biotechnology-derived products, and related compounds
used for JRA and JRA subsets
Medical devices intended for human use; Approved or cleared medical devices
evaluated by the Division of Anti-Infective Drug Products
Products for which batch/lot information is particularly important
Clinical investigations of medical devices
Requires analytical comparability per ICH Q5E
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.
drugs currently used to treat RA patients; currently approved traditional cyclooxygenase inhibitors
Stakeholders
6Possible to conduct the FIH trial in healthy volunteers
Primary source of experience data
Involved in assessing global disease activity in JRA trials
Dropouts are patients who, after a certain period of time in a trial, fail to provide clinical efficacy data.
Entity responsible for submitting applications under section 524B
FDA personnel to be consulted during planning stages.
Regulatory Context
Attributes
10Standard trial duration to establish efficacy for signs and symptoms
Measured at the end of the trial based on different definitions of improvement
basis for applying the pediatric rule to support labeling
Determined during the planning of a research study
Efficacy variables can be combined within patients (composite endpoint).
Statistical parameter to be controlled when handling multiplicity issues
sponsors should include confidence intervals on all reported results
Information such as hypotheses tested, parameters estimated, assumptions made, level of significance
Secondary efficacy variables are those that support the validity of the primary variables.
Primary efficacy variables are critical to the identification of the effectiveness of the product.
Identified Hazards
Hazards
6Potential for products to elicit antibodies which may block efficacy
May interfere with efficacy of biological agents over time
Safety concern if product heterogeneity is inconsistent
mitigate potential unwanted bias in learning or performance estimation
Serious dose-related adverse reactions associated with RA drug products.
Risk from disruption of critical host genes or activation of proto-oncogenes
Related CFR Sections (1)
- 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 →
See Also (8)
- Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Status: Draft)
- How to Comply with the Pediatric Research Equity Act (Status: Draft)
- Prussian Blue Drug Products — Submitting a New Drug Application (Status: Final)
- Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application (Status: Final)
- Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (Status: Final)
- Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff (Status: Final)
- Tropical Disease Priority Review Vouchers (Status: Final)
- Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry (Status: Draft)