Subjects: Drug Development - Digital Collections - National Library of Medicine Search Results

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NLM Digital Collections

Start Over Subjects Drug Development

1. Pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2020
Subject(s):: Clinical Studies as Topic
Drug Development
Pediatrics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Patient-focused drug development: collecting comprehensive and representative input : guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):: Drug Development
Feedback
Sampling Studies
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Community-acquired bacterial pneumonia: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):: Community-Acquired Infections
Drug Development
Pneumonia, Bacterial -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):: Drug Development
Healthcare-Associated Pneumonia -- drug therapy
Pneumonia, Bacterial -- drug therapy
Pneumonia, Ventilator-Associated -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Eosinophilic esophagitis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Drug Development
Eosinophilic Esophagitis -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Formal meetings between FDA and ANDA applicants of complex products under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Controlled correspondence related to generic drug development

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Development
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Science and tech spotlight: COVID-19 vaccine development

Publication:: [Washington, DC] : United States Government Accountability Office, May 2020
Subject(s):: COVID-19 Vaccines -- therapeutic use
Drug Development
United States

9. COVID-19: federal efforts accelerate vaccine and therapeutic development, but more transparency needed on emergency use authorizations : report to Congressional addressees

Publication:: Washington, DC : United States Government Accountability Office, November 2020
Subject(s):: COVID-19 Vaccines
Drug Approval
Drug Development
Disclosure
United States
United States. Department of Defense
United States. Department of Health and Human Services

10. Premenopausal women with breast cancer: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Breast Neoplasms -- drug therapy
Drug Development
Premenopause
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration