NLM Digital Collections

Search

Start Over Subjects Clinical Trials as Topic ✖Remove constraint Subjects: Clinical Trials as Topic Languages English ✖Remove constraint Languages: English Genre Guideline ✖Remove constraint Genre: Guideline Genre Technical Report ✖Remove constraint Genre: Technical Report Copyright Public domain ✖Remove constraint Copyright: Public domain Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

2. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):
Patient Outcome Assessment
Patient Reported Outcome Measures
Pulmonary Disease, Chronic Obstructive -- therapy
Surveys and Questionnaires
Clinical Trials as Topic
Outcome Assessment (Health Care)
Self-Assessment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Anti-Bacterial Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation -- standards
Drugs, Investigational -- pharmacokinetics
Intraabdominal Infections -- drug therapy
Microbiological Techniques -- standards
Drug Labeling -- standards
Endpoint Determination -- standards
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Antineoplastic Agents -- toxicity
Drug Approval
Drug Contamination
Research Design
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Use of electronic health record data in clinical investigations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):
Clinical Trials as Topic
Electronic Health Records -- utilization
Health Information Interoperability
Forms and Records Control
Informed Consent
Reproducibility of Results
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:
Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):
Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. Allergic rhinitis: developing drug products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):
Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

11. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):
Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

12. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

Publication:
Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
Subject(s):
Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2017
Subject(s):
Arrhythmias, Cardiac -- chemically induced
Arrhythmias, Cardiac -- diagnosis
Cardiac Electrophysiology -- methods
Cardiac Electrophysiology -- standards
Drug Approval
Electrocardiography -- standards
Long QT Syndrome -- chemically induced
Cardiotoxins
Clinical Trials as Topic
Congresses as Topic
Diagnosis, Computer-Assisted
Drug-Related Side Effects and Adverse Reactions
International Cooperation
Pharmaceutical Preparations -- administration & dosage
Reference Standards
Research Design
Sex Factors
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2017
Subject(s):
Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 12, 2017
Subject(s):
Clinical Trials as Topic
Demography
Device Approval
Research Design
Age Factors
Continental Population Groups
Ethnic Groups
Product Surveillance, Postmarketing
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Hepatitis C, Chronic -- drug therapy
Antiviral Agents -- pharmacokinetics
Drugs, Investigational -- pharmacokinetics
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. Recurrent herpes labialis: developing drugs for treatment and prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Drugs, Investigational -- therapeutic use
Herpes Labialis -- drug therapy
Herpes Labialis -- prevention & control
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.