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1581. Supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions during the Coronavirus Disease 2019 (COVID-19) public health emergency (revised): guidance for Industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, May 2022

Subject(s):

Compassionate Use Trials -- legislation & jurisprudence
COVID-19
Device Approval -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1582. Surgical staplers and staples for internal use: labeling recommendations : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, October 8, 2021

Subject(s):

Product Labeling
Surgical Staplers
Sutures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1583. Surgical sutures: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, April 11, 2022

Subject(s):

Device Approval
Sutures -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1584. Surging the public health workforce: lessons learned from the COVID-19 response at state, tribal, local, and territorial public health agencies

Author(s):

Lee, Katie Morrison, author
Bosold, Alyssa, author
Alvarez, Cindy, (Of Mathematica), author
Rittenhouse, Diane, author
Felt-Lisk, Sue, author
Miller, Faye, (Of Mathematica), author
Palo, Chris, author

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, September 2023

Subject(s):

COVID-19
Health Workforce
Local Government
Public Health
State Government
Surge Capacity
United States

1585. Surveying, leveling, and alignment laser products: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health , January 31, 2023

Subject(s):

Government Regulation
Lasers
Medical Device Legislation
Weights and Measures
United States
United States. Food and Drug Administration

1586. Sustaining programs for expectant and parenting teens: lessons learned from former Pregnancy Assistance Fund grantees

Author(s):

Asheer, Subuhi, author
Alamillo, Julia, author
Keating, Betsy, author
Knab, Jean, author

Publication:

[Washington, D.C.] : Department of Health and Human Services, Office of Adolescent Health, May 2017

Subject(s):

Government Programs
Pregnancy in Adolescence
Program Evaluation
United States

1587. Sustaining teen pregnancy prevention programs

Author(s):

Alamillo, Julia, author
Asheer, Subuhi, author
Keating, Betsy, author
Knab, Jean, author

Publication:

[Washington, D.C.] : Department of Health and Human Services, Office of Adolescent Health, February 2018

Subject(s):

Government Programs
Pregnancy in Adolescence -- prevention & control
United States

1588. Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, December 2017

Subject(s):

Anti-Bacterial Agents
Antifungal Agents
Investigational New Drug Application
Microbial Sensitivity Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1589. Tackling America's mental health and addiction crisis through primary care integration

Publication:

Washington, DC : Bipartisan Policy Center, March 2021

Subject(s):

Delivery of Health Care, Integrated -- organization & administration
Mental Health Services -- organization & administration
Primary Health Care -- organization & administration
Substance-Related Disorders -- therapy
United States

1590. Taking a teen pregnancy prevention program to the home: the AIM 4 Teen Moms experience

Publication:

[Washington, D.C.] : Department of Health and Human Services, Office of Adolescent Health, May 2014

Subject(s):

Pregnancy in Adolescence -- prevention & control
Los Angeles
United States

1591. Tale of two states: transforming child care in New Mexico and Alabama

Author(s):

Kerber, Lisa, 1967- author
Sabo, Jason, author
Smith, Linda K., author

Publication:

Washington, DC : Bipartisan Policy Center, May 2023

Subject(s):

Child Care -- economics
Child Care -- legislation & jurisprudence
Child Welfare -- legislation & jurisprudence
Financing, Government
Alabama
New Mexico

1592. Tax administration: IRS oversight of hospitals’ tax-exempt status : testimony before the Subcommittee on Oversight, Committee on Ways and Means, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, April 26, 2023

Subject(s):

Charities -- economics
Economics, Hospital -- legislation & jurisprudence
Government Regulation
Legislation, Medical
Organizations, Nonprofit
Tax Exemption -- legislation & jurisprudence
United States

1593. Technical assistance brief: implementation of inflation-indexed rebates for Part B drugs

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, February 2023

Subject(s):

Drug Costs
Government Regulation
Inflation, Economic
Medicare Part B
United States

1594. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, December 5, 2017

Subject(s):

Computer-Aided Design -- standards
Device Approval
Manufactured Materials -- standards
Materials Testing -- standards
Printing, Three-Dimensional -- standards
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1595. Technical considerations for medical devices with physiologic closed-loop control technology: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2023

Subject(s):

Equipment Design
Equipment Safety
Government Regulation
Medical Device Legislation
Monitoring, Physiologic
United States

1596. Technical considerations for non-clinical assessment of medical devices containing nitinol: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, July 9, 2021

Subject(s):

Alloys
Equipment Design
Equipment Safety
Nickel
Titanium
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1597. Technical performance assessment of quantitative imaging in radiological device premarket submissions: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, June 16, 2022

Subject(s):

Device Approval
Technology, Radiologic -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1598. Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022

Subject(s):

Clinical Trials as Topic
Non-alcoholic Fatty Liver Disease -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1599. Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022

Subject(s):

Clinical Trials as Topic
Non-alcoholic Fatty Liver Disease -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1600. Technology assessment: Vaccine development : capabilities and challenges for addressing infectious diseases : report to congressional committees

Publication:

Washington, DC : United States Government Accountability Office, November 2021

Subject(s):

COVID-19 -- economics
Government Regulation
Stakeholder Participation
Vaccine Development -- economics
United States