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1. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff


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


4. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases


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


7. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool


8. Anthrax: developing drugs for prophylaxis of inhalational anthrax


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


13. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases


17. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment


18. Recurrent herpes labialis: developing drugs for treatment and prevention


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