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2. Anthrax: developing drugs for prophylaxis of inhalational anthrax


3. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment


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


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


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


9. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff


10. Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff


11. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products


14. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff


15. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers