Description
The purpose of his guidance is to assist sponsors who are developing drugs, devices, or 20 biological products (medical products) to treat the underlying pathophysiology and structural progression of osteoarthritis (OA).2 21
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
3Requires analytical comparability per ICH Q5E
Clinical investigations of medical devices
Clinical investigations of drugs, including human drugs and biological products
Stakeholders
2Entities involved in the development of bispecific antibodies
Assist sponsors in the nonclinical evaluation
Regulatory Context
Regulatory Activities
2Pathway based on clinical endpoints or validated surrogate endpoints
Pathway for drugs and biologics for serious conditions; Regulatory pathway supported by surrogate or intermediate endpoints; Regulatory pathway based on surrogate or intermediate endpoints; Pathway for products based on surrogate or intermediate clinical endpoints
Attributes
3Common measures used to predict treatment effects
Focus of the guidance for drug development
Evidence required to include software information in the PI
Technical Details
Processes
2Conducted to review submissions and verify quality of evidence; Programs used to perform the statistical analysis.
General issue not specifically addressed in this guidance but referenced to ICH.
Clinical Concepts
4Direct measures of how patients function and feel
A clinical outcome of interest that structural endpoints aim to delay or avoid.
Measures used to assess pain and function in OA approvals to date.
manifestations of obesity beyond excess adiposity
Standards & References
Specifications
1The primary focus of the guidance for assessing OA disease progression.
ICH References (2)
Choice of Control Group in Clinical Trials.
Statistical Principles for Clinical Trials; Discourages deterministic procedures due to high risk of bias; Notes that the use of Bayesian methods in clinical trials may be considered.
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (7)
- Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Draft Guidance for Industry
- Systemic Lupus Erythematosus --Developing Medical Products for Treatment
- Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors
- Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry
- Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
- Use of Data Monitoring Committees in Clinical Trials
- Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling