FDA指导原则-Guidance for industry-Rheumatoid Arthritis-Developing Drug Products for Treatment

1、 Contains Nonbinding Recommendations Draft Not for Implementation 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 REFERENCES Literary ACR/EULAR, 2011, Provisional Definition of Remission in Rheumatoid Arthritis for Clini

2、cal Trials, Arthritis Rheum., Mar;63(3:573-86. American College of Rheumatology, 2011, Clinical Trial Priorities and Design Conference (July 22-23, 2010, Arthritis Rheum., Aug;63(8:2151-6. American College of Rheumatology Committee to Reevaluate Improvement Criteria, 2007, A Proposed Revision to the

3、 ACR20: The Hybrid Measure of American College of Rheumatology Response, Arthritis Rheum., Mar 15;57(2:193-202. Singh, JA, 2012, Update of the 2008 American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid

4、 Arthritis, Arthritis Care Res., May;64(5:625-39. Guidances Draft guidance for industry and FDA staff Applying Human Factors and Usability Engineering to Optimize Medical Device Design Draft guidance for industry and FDA staff Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products Guidance for industry and FDA premarket and design control reviewers Medical Device UseSafety: Incorporating Human Factors Engineering into Risk Management ICH guidance for industry E1A The Extent of Population Exposure to Assess Clinical Safety: F