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21. Complicated intra-abdominal infections: developing drugs for treatment


22. Complicated urinary tract infections: developing drugs for treatment


25. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff


28. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff


30. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff


32. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff


34. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff


35. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment


36. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population


37. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)


40. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)