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- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019
- Subject(s):
- Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
Biological Products -- classification
Cell- and Tissue-Based Therapy -- classification
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 Biologics Evaluation and Research, March 2019
- Subject(s):
- Guidelines as Topic
Consensus
Device Approval
Drug Approval
Government Agencies
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Center for Biologics Evaluation and Research (U.S.)
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
- Subject(s):
- Equipment Safety
Lasers -- classification
Lasers -- standards
Device Approval
Lasers -- adverse effects
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, June 27, 2019
- Subject(s):
- Device Approval
Transducers
Ultrasonography -- instrumentation
Equipment Safety
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, July 11, 2019
- Subject(s):
- Clinical Trials as Topic
Device Approval
Data Collection
Ethics Committees, Research
Informed Consent
Single-Case Studies 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, August 30, 2019
- Subject(s):
- Cost-Benefit Analysis
Device Approval
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019
- Subject(s):
- Clinical Trials as Topic
Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
Drugs, Investigational
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, December 2019
- Subject(s):
- Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Author(s):
- White, Robert S., (Compliance Attorney and member of the Oklahoma Bar), author
- Publication:
- [Toronto, Ontario] : Thomson Reuters, 19-December-2022
- Subject(s):
- Device Approval
Product Surveillance, Postmarketing
Equipment Safety
Medical Device Recalls -- legislation & jurisprudence
United States
United States. Food and Drug Administration
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, April 14, 2023
- Subject(s):
- Angioplasty, Balloon, Coronary
Cardiac Catheters
Device Approval
Government Regulation
United States