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Start Over Publication Year 2017 ✖Remove constraint Publication Year: 2017

191. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):
Clinical Trials as Topic -- standards
Human Experimentation -- standards
Informed Consent -- standards
Ethics Committees, Research
Ethics, Research
Informed Consent -- ethics
Research Subjects
Risk
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

193. Federal subsidies for health insurance coverage for people under age 65: 2017 to 2027

Publication:
Washington, D.C. : Congressional Budget Office, September 2017
Subject(s):
Cost Sharing -- statistics & numerical data
Cost Sharing -- trends
Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
Insurance, Health -- statistics & numerical data
Insurance, Health -- trends
Adult
Child
Child Health Services
Federal Government
Forecasting
Health Benefit Plans, Employee
Infant
Medicaid
Medically Uninsured -- statistics & numerical data
Medicare
Middle Aged
State Government
Humans
United States
United States.
State Children's Health Insurance Program (U.S.)

194. Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):
Anti-Infective Agents, Local
Consumer Product Safety
Hand Sanitizers
Nonprescription Drugs
Anti-Bacterial Agents
Anti-Infective Agents, Local -- adverse effects
Soaps
Triclosan
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

195. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):
Drug Approval
Drug Industry -- standards
Drugs, Generic
Guideline Adherence
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

196. 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.

197. FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 29, 2017
Subject(s):
Device Approval
Small Business
Eligibility Determination
Taxes
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

198. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017
Subject(s):
Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
Data Collection
Data Interpretation, Statistical
Decision Making
Device Approval
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

199. Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 1, 2017
Subject(s):
Advisory Committees -- organization & administration
Device Approval
Equipment and Supplies -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

200. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2017
Subject(s):
Equipment and Supplies -- standards
Equipment Design -- standards
Equipment Safety -- standards
Device Approval
Equipment Failure
Information Dissemination
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.