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Titles
- Adaptive designs for clinical trials of drugs and biologics1
- Allergic rhinitis: developing drug products for treatment1
- Anthrax: developing drugs for prophylaxis of inhalational anthrax1
- BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment1
- Bacterial vaginosis: developing drugs for treatment1
- Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff1
- Considerations for building federal data capacity for patient-centered outcomes research related to intellectual and developmental disabilities1
- Considerations in demonstrating interchangeability with a reference product1
- Delayed graft function in kidney transplantation: developing drugs for prevention1
- Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment1
- E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)1
- E17 general principles for planning and design of multiregional clinical trials1
- E6(R2) good clinical practice: integrated addendum to ICH E6(R1)1
- Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products1
- Epidermolysis bullosa: developing drugs for treatment of cutaneous manifestations1
- Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders1
- 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 staff1
- Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff1
- General principles for evaluating the abuse deterrence of generic solid oral opioid drug products1
- Investigational enzyme replacement therapy products: nonclinical assessment1