Subjects: Clinical Trials as Topic and United States. Department of Health and Human Services. - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Clinical Trials as Topic ✖ Subjects United States. Department of Health and Human Services. ✖

21. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

Publication:: Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

22. Cancer clinical trial eligibility criteria: brain metastases

Publication:: Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Brain Neoplasms
Clinical Trials as Topic
Eligibility Determination
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

23. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Eligibility Determination
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

24. Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

25. Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff

Publication:: Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
Subject(s):: Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

26. Statistical considerations for clinical trials during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
Subject(s):: Clinical Trials as Topic
Statistics as Topic
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

28. Clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):: Drug Interactions
Clinical Trials as Topic
Cytochrome P-450 Enzyme System
Drugs, Investigational
Membrane Transport Proteins
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

29. Human gene therapy for retinal disorders

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):: Clinical Trials as Topic
Genetic Therapy
Drug Evaluation, Preclinical
Retinal Diseases -- therapy
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

30. Human gene therapy for rare diseases

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):: Drug Development
Genetic Therapy
Rare Diseases -- therapy
Clinical Trials as Topic
Drug Evaluation, Preclinical
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.