Subjects: Clinical Trials as Topic -- standards - Digital Collections - National Library of Medicine Search Results

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NLM Digital Collections

Start Over Subjects Clinical Trials as Topic -- standards

1. Vulvovaginal candidiasis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Candidiasis, Vulvovaginal -- drug therapy
Clinical Trials as Topic -- standards
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Amyotrophic lateral sclerosis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):: Amyotrophic Lateral Sclerosis -- drug therapy
Clinical Trials as Topic -- standards
Drug Development -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. E8(R1) general considerations for clinical studies

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Clinical Studies as Topic -- standards
Clinical Trials as Topic -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Clinical Trials as Topic -- standards
Human Experimentation -- standards
Informed Consent -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Muscular Dystrophies -- drug therapy
Muscular Dystrophy, Duchenne -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Special protocol assessment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Approval
Drug Evaluation, Preclinical -- standards
Research Design
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Clinical trial imaging endpoint process standards

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Trials as Topic -- standards
Diagnostic Imaging -- standards
Endpoint Determination -- standards
Research Design -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Endpoint Determination
Hypogonadism -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration