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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

nlm:nlmuid-101712948-pdf

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

nlm:nlmuid-101712951-pdf

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

nlm:nlmuid-101713206-pdf

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

nlm:nlmuid-101713258-pdf

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

nlm:nlmuid-101734084-pdf

8. Anthrax: developing drugs for prophylaxis of inhalational anthrax

nlm:nlmuid-101734212-pdf

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

nlm:nlmuid-101734269-pdf

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

nlm:nlmuid-101734398-pdf

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

nlm:nlmuid-101719919-pdf

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

nlm:nlmuid-101719926-pdf

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

nlm:nlmuid-101719981-pdf