NLM Digital Collections

Search

Start Over Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services. Languages English ✖Remove constraint Languages: English Publication Year 2017 ✖Remove constraint Publication Year: <span class="single" data-blrl-single="2017">2017</span>

31. Health document submission requirements for tobacco products: (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, October 2017
Subject(s):
Documentation -- standards
Tobacco Products -- standards
Drug Approval
Health
Terminology as Topic
Tobacco Products -- adverse effects
Tobacco Products -- toxicity
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

32. Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):
Registries -- standards
Tobacco Products -- standards
Manufacturing and Industrial Facilities -- standards
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

33. Foster care: HHS has taken steps to support states' oversight of psychotropic medications, but additional assistance could further collaboration : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):
Child Welfare
Drug Utilization -- statistics & numerical data
Foster Home Care
Inappropriate Prescribing -- prevention & control
Psychotropic Drugs -- therapeutic use
Child
Government Regulation
Information Dissemination
Interinstitutional Relations
State Government
Humans
United States
United States. Department of Health and Human Services.

34. Defense civil support: DOD, HHS, and DHS should use existing coordination mechanisms to improve their pandemic preparedness : report to the Committee on Armed Services, House of Representatives

Publication:
Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):
Civil Defense
Interinstitutional Relations
Pandemics
Disaster Planning
Federal Government
Humans
United States
United States. Department of Defense.
United States. Department of Health and Human Services.
United States. Department of Homeland Security.

35. Drug-free community support program: agencies have strengthened collaboration but could enhance grantee compliance and performance monitoring : report to Congressional committees

Publication:
Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):
Community Health Services
Community-Institutional Relations
Interinstitutional Relations
Substance-Related Disorders -- prevention & control
Adolescent
Financing, Government
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.

36. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

Publication:
Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017
Subject(s):
Civil Defense -- legislation & jurisprudence
Device Approval
Drug Approval
Emergencies
Terrorism
Emergency Medical Services
Equipment Safety
Off-Label Use
Public Health
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Food and Drug Administration.

37. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

Publication:
Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
Subject(s):
Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

38. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2017
Subject(s):
Arrhythmias, Cardiac -- chemically induced
Arrhythmias, Cardiac -- diagnosis
Cardiac Electrophysiology -- methods
Cardiac Electrophysiology -- standards
Drug Approval
Electrocardiography -- standards
Long QT Syndrome -- chemically induced
Cardiotoxins
Clinical Trials as Topic
Congresses as Topic
Diagnosis, Computer-Assisted
Drug-Related Side Effects and Adverse Reactions
International Cooperation
Pharmaceutical Preparations -- administration & dosage
Reference Standards
Research Design
Sex Factors
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

40. 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.