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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
- Subject(s):
- Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
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 2018
- Subject(s):
- Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- College Park, MD : Center for Food Safety and Applied Nutrition, June 2023
- Subject(s):
- Arsenic
Food Safety
Food Supply
Government Regulation
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
- Subject(s):
- Biological Products
Drug Development -- legislation & jurisprudence
Government Regulation
Leukemia, Myeloid, Acute -- drug therapy
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
- Subject(s):
- Biological Products
Drug Industry
Government Regulation
Pharmaceutical Preparations
Randomized Controlled Trials as Topic
United States
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
- Subject(s):
- Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
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, September 2017
- Subject(s):
- Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
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, 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.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, June 2023
- Subject(s):
- Biological Products -- standards
Blood Platelets
Government Regulation
Platelet Transfusion
Refrigeration
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
- Subject(s):
- Forms as Topic
Government Regulation
Product Surveillance, Postmarketing
United States
United States.
United States.
- 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.
- 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.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2023
- Subject(s):
- Government Regulation
Medical Device Legislation
Microbial Sensitivity Tests -- standards
Product Labeling
United States
- 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 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.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, November 17, 2023
- Subject(s):
- Computer Simulation
Device Approval
Government Regulation
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2022
- Subject(s):
- Administration, Oral
Drug Approval
Drugs, Investigational
Food-Drug Interactions
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
- Subject(s):
- Fees and Charges
Investigational New Drug Application -- economics
Prescription Drugs -- economics
Biological Products -- economics
Orphan Drug Production -- economics
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, June 2018
- Subject(s):
- Biosimilar Pharmaceuticals -- economics
Fees and Charges
Investigational New Drug Application -- economics
Drug Evaluation -- economics
Parenteral Nutrition Solutions -- economics
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 2018
- Subject(s):
- Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
Research Design
Humans
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, October 2023
- Subject(s):
- Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Pharmaceutical Preparations
Risk Assessment
United States
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
- Subject(s):
- Communication
Drug Industry
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- College Park, MD : Center for Food Safety and Applied Nutrition, December 2022
- Subject(s):
- Advisory Committees
Consumer Product Safety
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
- Subject(s):
- Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2023
- Subject(s):
- Data Collection
Device Approval
Government Regulation
Medical Device Legislation
United States
United States.
United States.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
- Subject(s):
- Drug Industry
Government Regulation
Quality Control
Reference Standards
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
- Subject(s):
- Clinical Trials as Topic
Government Regulation
Neoplasms -- drug therapy
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, Maryland] : Center for Devices and Radiological Health, September 29, 2017
- Subject(s):
- Device Approval -- standards
Documentation -- standards
Humans
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, 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.
- 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.
- 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 : 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.
- Publication:
- Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017
- Subject(s):
- Biological Products -- classification
Classification -- methods
Equipment and Supplies -- classification
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 28, 2022
- Subject(s):
- Clinical Decision-Making
Decision Making, Computer-Assisted
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
- Subject(s):
- Contraceptives, Oral
Drug Evaluation
Drug Industry
Drug Interactions
Government Regulation
United States
- 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
Observer Variation
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Author(s):
- American Medical Association.
- Publication:
- Philadelphia : T.K. and P.G. Collins, 1854
- Subject(s):
- Societies, Medical
Codes of Ethics
United States
American Medical Association.
- Author(s):
- American Medical Association.
- Publication:
- Concord [N.H.] : Printed by Asa McFarland, 1850
- Subject(s):
- Societies, Medical
Codes of Ethics
United States
American Medical Association.
- Author(s):
- American Medical Association.
- Publication:
- Philadelphia : T.K. and P.G. Collins, printers, 1848
- Subject(s):
- Societies, Medical
Codes of Ethics
United States
American Medical Association.
- Author(s):
- Massachusetts Medical Society, author.
- Publication:
- [Massachusetts?] : [publisher not identified], [1880?]
- Subject(s):
- Societies, Medical
Codes of Ethics
Massachusetts
Massachusetts Medical Society.
- Publication:
- [Los Angeles] : Office of the Superintendent, Los Angeles City Schools, 1948
- Subject(s):
- Communicable Disease Control
Schools
California
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
- Subject(s):
- Biological Products
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
- Subject(s):
- Drug Approval
Drugs, Generic
Government Regulation
Therapeutic Equivalency
United States
United States. Food and Drug Administration
- Publication:
- Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, September 2017
- Subject(s):
- Product Labeling -- standards
Product Packaging -- standards
Tobacco Products -- standards
Guideline Adherence
Humans
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, October 2023
- Subject(s):
- Blood Banking -- standards
Blood Donation -- standards
Blood Donors
Donor Selection -- standards
Government Regulation
Guideline Adherence
Plasma
United States
- 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.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
- Subject(s):
- Anti-Bacterial Agents -- therapeutic use
Anti-Infective Agents, Urinary -- therapeutic use
Clinical Trials as Topic -- standards
Drug Evaluation
Microbiological Techniques -- standards
Urinary Tract Infections -- drug therapy
Endpoint Determination -- standards
Research Design -- standards
Urinary Tract Infections -- complications
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 2018
- Subject(s):
- Drug Compounding -- standards
Humans
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, January 2018
- Subject(s):
- Drug Compounding -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.