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- Publication:
- Washington, DC : United States Government Accountability Office, December 2017
- Subject(s):
- Drug Approval
Drugs, Generic
Therapeutic Equivalency
Chemistry, Pharmaceutical
Doxorubicin
Drug Development
Enoxaparin
Glatiramer Acetate
Gluconates
Propofol
Humans
United States
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2023
- Subject(s):
- Cannabis
Drug Development
Government Regulation
Medical Marijuana
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
- Subject(s):
- Biological Products
Drug Development
Government Regulation
Pragmatic Clinical Trials as Topic
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
- Subject(s):
- Biological Products
Clinical Studies as Topic
Drug Development
Government Regulation
Infant Health
Pharmacology, Clinical
United States
United States. Food and Drug Administration
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- Publication:
- [Washington, DC] : United States Government Accountability Office, May 2020
- Subject(s):
- COVID-19 Vaccines -- therapeutic use
Drug Development
United States
- 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
- 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
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
- Subject(s):
- Antibodies, Bispecific
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
- Subject(s):
- Anti-Infective Agents
Drug Development
Pediatrics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2021
- Subject(s):
- Biosimilar Pharmaceuticals
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2021
- Subject(s):
- Biological Products
Drug Approval
Drug Development
Electronic Mail
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- 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.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, February 2022
- Subject(s):
- Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Pharmacokinetics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
- Subject(s):
- Dosage Forms -- standards
Drug Approval
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Subject(s):
- Biological Products -- standards
Drug Approval
Drug Development
Nanostructures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Subject(s):
- Drug Approval
Drug Development
Hepatitis B -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
- Subject(s):
- Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, February 2019
- Subject(s):
- Buprenorphine -- therapeutic use
Drug Development
Opioid-Related Disorders -- drug therapy
Buprenorphine -- administration & dosage
Clinical Trials as Topic
Delayed-Action Preparations
Narcotic Antagonists
Opiate Substitution Treatment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
- Subject(s):
- Drug Development
HIV Infections -- prevention & control
Pre-Exposure Prophylaxis
Adolescent
Child
Clinical Trials as Topic
HIV Infections -- drug therapy
HIV-1
Infant
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
- Subject(s):
- Biomarkers
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Hematologic Neoplasms -- drug therapy
Investigational New Drug Application
Neoplasm, Residual
Endpoint Determination
Leukemia, Lymphocytic, Chronic, B-Cell -- drug therapy
Leukemia, Myelogenous, Chronic, BCR-ABL Positive -- drug therapy
Leukemia, Myeloid, Acute -- drug therapy
Leukemia, Promyelocytic, Acute -- drug therapy
Multiple Myeloma -- drug therapy
Patient Selection
Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy
Prognosis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
- Subject(s):
- Clinical Trials as Topic
Drug Development
Urinary Tract Infections -- drug therapy
Pharmacokinetics
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
- Subject(s):
- Clinical Trials as Topic
Drug Development
Vaginosis, Bacterial -- drug therapy
Pharmacokinetics
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- 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
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
- Subject(s):
- Drug Development
Drug Industry
Government Regulation
Risk Management
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
- Subject(s):
- Drug Development
Government Regulation
Nicotine Chewing Gum
Smoking Cessation
Smoking Cessation Agents
Tobacco Use Cessation Devices
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2023
- Subject(s):
- Biological Products
Drug Compounding
Drug Development
Drug Industry
Government Regulation
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
- Subject(s):
- Drug Development
Drug Industry
Government Regulation
Nasal Polyps -- drug therapy
Sinusitis -- drug therapy
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
- Subject(s):
- Carcinogens
Drug Contamination -- prevention & control
Drug Development
Drug Industry
Government Regulation
Mutagenicity Tests
Mutagens
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 2023
- Subject(s):
- Bioengineering
Device Approval
Drug Development
Drug Industry
Ergonomics
Government Regulation
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
- Subject(s):
- Drug Development
Drug Industry
Government Regulation
Mycobacterium avium Complex -- pathogenicity
Mycobacterium Infections, Nontuberculous -- drug therapy
United States
- Publication:
- [Silver Spring, MD] : Center for Biologics Evaluation and Research, October 2023
- Subject(s):
- COVID-19 Vaccines -- standards
Drug Development
Drug Industry
Government Regulation
Vaccine Development
United States
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
- Subject(s):
- Clinical Trials as Topic
Drug Development
Drug Industry
Government Regulation
Outcome Assessment, Health Care
United States
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
- Subject(s):
- Clinical Trials as Topic
Drug Development
Drug Industry
Government Regulation
Neoplasms -- drug therapy
Patient Reported Outcome Measures
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
- Subject(s):
- Biological Products
Drug Development
Drug Industry
Government Regulation
Rare Diseases -- drug therapy
United States