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

803. Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders

804. Acne vulgaris: establishing effectiveness of drugs intended for treatment

805. Bioanalytical method validation

807. Anthrax: developing drugs for prophylaxis of inhalational anthrax

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

809. Complicated urinary tract infections: developing drugs for treatment

810. Medical product communications that are consistent with the FDA-required labeling: questions and answers