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Titles
- Allergic rhinitis: developing drug products for treatment1
- Anthrax: developing drugs for prophylaxis of inhalational anthrax1
- Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases1
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment1
- Bacterial vaginosis: developing drugs for treatment1
- Cancer clinical trial eligibility criteria: brain metastases1
- Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs1
- Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections1
- Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies1
- Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment1
- Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool1
- Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff1
- Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases1
- Clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions1
- Complicated intra-abdominal infections: developing drugs for treatment1
- Considerations in demonstrating interchangeability with a reference product1
- Delayed graft function in kidney transplantation: developing drugs for prevention1
- Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older1
- E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)1