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1501. E9(R1) statistical principles for clinical trials: addendum : estimands and sensitivity analysis in clinical trials

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2021

Subject(s):

Clinical Trial Protocols as Topic
Clinical Trials as Topic
Statistics as Topic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1502. Premenopausal women with breast cancer: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2021

Subject(s):

Breast Neoplasms -- drug therapy
Drug Development
Premenopause
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1503. Product identifiers under the Drug Supply Chain Security Act: questions and answers

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2021

Subject(s):

Drug Industry
Drug Labeling
Government Regulation
Security Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1504. Drug Supply Chain Security Act implementation: identification of suspect product and notification

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2021

Subject(s):

Drug Industry
Drug and Narcotic Control
Security Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1505. Enforcement policy regarding use of National Health Related Item Code and National Drug Code numbers on device labels and packages: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, May 21, 2021

Subject(s):

Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1506. Chemistry, manufacturing, and controls changes to an approved application: certain biological products

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2021

Subject(s):

Biological Products
Drug Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1507. Medicare Advantage enrollment update 2021

Author(s):

Shrestha, Mina, author
Ullrich, Fred, author
Mueller, Keith, author

Publication:

Iowa City, IA : Rural Policy Research Institute, September 2021

Subject(s):

Medicare Part C -- statistics & numerical data
Medicare Part C -- trends
Fee-for-Service Plans -- trends
Health Maintenance Organizations -- trends
Preferred Provider Organizations -- trends
Rural Population
Urban Population
United States

1508. COVID-19 cases and deaths, metropolitan and nonmetropolitan counties over time: (update)

Author(s):

Ullrich, Fred, author
Mueller, Keith, author

Publication:

Iowa City, IA : Rural Policy Research Institute, February 2022

Subject(s):

COVID-19 -- epidemiology
COVID-19 -- mortality
Rural Population -- statistics & numerical data
Urban Population -- statistics & numerical data
United States

1509. Sources of insurance coverage in nonmetropolitan areas: the role of public and private insurance since 2009

Author(s):

Li, Linda, author
Najarian, Matthew, author
Barker, Abigail, author
McBride, Timothy D., author
Mueller, Keith J., author

Publication:

Iowa City, IA : Rural Policy Research Institute, March 2021

Subject(s):

Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
Insurance, Health -- statistics & numerical data
Insurance, Health -- trends
Private Sector
Public Sector
Rural Health Services -- statistics & numerical data
Rural Health Services -- trends
Rural Population
Urban Population
United States

1510. Geographic expansion of Medicaid managed care organizations: assessing access to primary care in nonmetropolitan counties

Author(s):

Li, Linda, author
Najarian, Matthew, author
Barker, Abigail, author
Kemper, Leah, author
McBride, Timothy D., author
Mueller, Keith J., author

Publication:

Iowa City, IA : Rural Policy Research Institute, March 2021

Subject(s):

Health Services Accessibility -- statistics & numerical data
Managed Care Programs -- statistics & numerical data
Medicaid -- statistics & numerical data
Primary Health Care -- statistics & numerical data
Rural Health Services -- statistics & numerical data
Rural Population
United States

1511. Trends in nursing home closures in nonmetropolitan and metropolitan counties in the United States: 2008-2018

Author(s):

Sharma, Hari, author
Baten, Redwan Bin Abdul, author
Ullrich, Fred, author
MacKinney, A. Clinton, author
Mueller, Keith J., author

Publication:

Iowa City, IA : Rural Policy Research Institute, February 2021

Subject(s):

Health Facility Closure -- statistics & numerical data
Health Facility Closure -- trends
Nursing Homes -- statistics & numerical data
Rural Population
Urban Population
United States

1512. Enforcement policy regarding use of national health related item code and national drug code numbers on device labels and packages: guidance for industry and Food and Drug Administration Staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, May 21, 2021

Subject(s):

Government Regulation
Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1513. Medicare Advantage enrollment update: 2019

Author(s):

Ali, Abdinasir K., author
Ullrich, Fred, author
Mueller, Keith, author

Publication:

Iowa City, IA : Rural Policy Research Institute, October 2020

Subject(s):

Medicare Part C -- statistics & numerical data
Medicare Part C -- trends
Fee-for-Service Plans -- trends
Health Maintenance Organizations -- trends
Preferred Provider Organizations -- trends
Rural Population
Urban Population
United States

1514. Pharmacy vaccination service availability in nonmetropolitan counties (V3)

Author(s):

Ullrich, Fred, author
Ullrich, Fred, author
Mueller, Keith, author

Publication:

Iowa City, IA : Rural Policy Research Institute, February 2021

Subject(s):

COVID-19 Vaccines -- supply & distribution
Pharmacies -- supply & distribution
Rural Health Services -- statistics & numerical data
Rural Population
United States

1515. CBO's simulation model of new drug development

Author(s):

Adams, Christopher P., author

Publication:

[Washington, DC] : Congressional Budget Office, August 2021

Subject(s):

Drug Development -- economics
Models, Economic
United States

1516. Implanted brain-computer interface (BCI) devices for patients with paralysis or amputation: non-clinical testing and clinical considerations : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021

Subject(s):

Amputation, Surgical
Brain-Computer Interfaces
Equipment Design
Equipment Safety
Paralysis
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1517. S5(R3) detection of reproductive and developmental toxicity for human pharmaceuticals

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2021

Subject(s):

Drug-Related Side Effects and Adverse Reactions
Reproductive Physiological Phenomena -- drug effects
Toxicity Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1518. Patient engagement in the design and conduct of medical device clinical studies: guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022

Subject(s):

Clinical Studies as Topic
Device Approval
Patient Participation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1519. Development of anti-infective drug products for the pediatric population

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, December 2021

Subject(s):

Anti-Infective Agents
Drug Development
Pediatrics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1520. 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

1521. Enforcement policy for viral transport media during the coronavirus disease 2019 (COVID19) public health emergency (revised): guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

Publication:

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

Subject(s):

Culture Media
Specimen Handling
Transportation
Virus Diseases
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1522. Non-clinical and clinical investigation of devices used for the treatment of benign prostatic hyperplasia (BPH): guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, December 27, 2021

Subject(s):

Device Approval
Prostatic Hyperplasia -- therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1523. Enforcement policy for face masks, barrier face coverings, face shields, surgical masks, and respirators during the coronavirus disease (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, September 2021

Subject(s):

COVID-19
Masks
N95 Respirators
Personal Protective Equipment
Respiratory Protective Devices
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1524. Development of abbreviated new drug applications during the COVID-19 pandemic: questions and answers

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, September 8, 2021

Subject(s):

COVID-19
Drug Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1525. Voluntary sodium reduction goals: target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods

Publication:

[Silver Spring, MD] : Center for Food Safety and Applied Nutrition, October 2021

Subject(s):

Food Handling
Food-Processing Industry
Sodium, Dietary
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1526. Nonmetastatic castration-resistant prostate cancer: considerations for metastasis-free survival endpoint in clinical trials

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, August 2021

Subject(s):

Clinical Trials as Topic
Prostatic Neoplasms, Castration-Resistant
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1527. Field alert report submission: questions and answers

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2021

Subject(s):

Drug Approval
Research Design
Research Report
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1528. Unique Device Identification System: form and content of the unique device identifier (UDI) : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, July 7, 2021

Subject(s):

Equipment and Supplies
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1529. Electronic prescribing of controlled substances among office-based physicians: 2017

Author(s):

Parasrampuria, Sonal, author
Blanco, Martín, author
Barker, Wesley, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, September 2019

Subject(s):

Controlled Substances
Electronic Prescribing -- statistics & numerical data
Practice Patterns, Physicians' -- statistics & numerical data
Prescription Drug Diversion -- prevention & control
Electronic Health Records
Medicare Part D
United States
United States. Department of Health and Human Services

1530. Submission of plans for cigarette packages and cigarette advertisements (revised)

Publication:

Silver Spring, MD : Center for Tobacco Products, July 2021

Subject(s):

Advertising
Government Regulation
Product Labeling
Tobacco Products
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1531. Electronic health record adoption and interoperability among U.S. skilled nursing facilities and home health agencies in 2017

Author(s):

Henry, JaWanna, author
Pylypchuk, Yuriy, author
Patel, Vaishali, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, November 2018

Subject(s):

Electronic Health Records -- statistics & numerical data
Health Information Interoperability -- statistics & numerical data
Home Care Services -- statistics & numerical data
Skilled Nursing Facilities -- statistics & numerical data
Diffusion of Innovation
United States
United States. Department of Health and Human Services

1532. Individuals' use of online medical records and technology for health needs

Author(s):

Patel, Vaishali, author
Johnson, Christian, MPH, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, April 2018

Subject(s):

Electronic Health Records -- statistics & numerical data
Mobile Applications
Patient Portals
Smartphone
United States
United States. Department of Health and Human Services

1533. Variation in interoperability among U.S. non-federal acute care hospitals in 2017

Author(s):

Pylypchuk, Yuriy, author
Johnson, Christian, MPH, author
Henry, JaWanna, author
Ciricean, Diana, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, November 2018

Subject(s):

Electronic Health Records -- statistics & numerical data
Health Information Interoperability -- statistics & numerical data
Hospitals -- statistics & numerical data
Information Dissemination
United States
United States. Department of Health and Human Services

1534. Electronic prescribing of controlled substances among Medicare Part D prescribers: 2015-2016

Author(s):

Jensen, Christian, 1833-1916 author
Barker, Wesley, author
Pylypchuk, Yuriy, author
Parasrampuria, Sonal, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, April 2019

Subject(s):

Controlled Substances
Electronic Prescribing -- statistics & numerical data
Medicare Part D -- trends
State Government
United States
United States. Department of Health and Human Services

1535. Hospitals' use of electronic health records data: 2015-2017

Author(s):

Parasrampuria, Sonal, author
Henry, Jawanna, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, April 2019

Subject(s):

Electronic Health Records -- trends
Health Information Interoperability -- trends
Hospitals -- trends
United States
United States. Department of Health and Human Services

1536. Electronic capabilities for patient engagement among U.S. non-federal acute care hospitals: 2013-2017

Author(s):

Henry, JaWanna, author
Barker, Wes, author
Kachay, Lolita, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, April 2019

Subject(s):

Electronic Health Records -- trends
Hospitals -- trends
Patient Portals -- trends
United States
United States. Department of Health and Human Services

1537. The prices that commercial health insurers and Medicare pay for hospitals’ and physicians’ services

Author(s):

Cohen, Michael, author
Maeda, Jared, author
Pelech, Daria, author

Publication:

[Washington, DC] : Congressional Budget Office, January 2022

Subject(s):

Health Care Costs -- statistics & numerical data
Hospital Costs -- statistics & numerical data
Insurance, Health -- economics
Medicare -- economics
United States

1538. Paying for drugs in Medicare Part D under current law and under proposals to redesign the program

Author(s):

Baker, Colin, author
Laughery, Scott, author

Publication:

[Washington, DC] : Congressional Budget Office, November 2021

Subject(s):

Cost Control
Drug Costs
Medicare Part D -- organization & administration
United States

1539. Prescription drugs: spending, use, and prices

Author(s):

Hayford, Tamara, author
Austin, David, author

Publication:

[Washington, DC] : Congressional Budget Office, January 2022

Subject(s):

Drug Costs
Health Expenditures -- trends
Medicaid -- economics
Medicare Part D -- economics
Prescription Drugs -- economics
United States

1540. Health coverage under the Affordable Care Act: enrollment trends and state estimates

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, June 5, 2021

Subject(s):

Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
State Government
United States
United States. Department of Health and Human Services
United States.

1541. Considerations for building federal data capacity for patient-centered outcomes research related to intellectual and developmental disabilities

Author(s):

Dhopeshwarkar, Rina, author
Heaney-Huls, Krysta, author
Hovey, Lauren, author
Leaphart, Desirae, author
Dullabh, Prashila, author

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, September 22, 2021

Subject(s):

Data Collection
Developmental Disabilities
Intellectual Disability
Patient-Centered Care
Research Design
United States
United States. Department of Health and Human Services

1542. Associations between county-level vaccination rates and COVID-19 outcomes among Medicare beneficiaries

Author(s):

Samson, Lok Wong, author
Tarazi, Wafa, author
Orav, E. John, author
Sheingold, Steven, author
De Lew, Nancy, author
Sommers, Benjamin D., author

Publication:

Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, October 5, 2021

Subject(s):

COVID-19 -- epidemiology
COVID-19 Vaccines
Medicare
Outcome and Process Assessment, Health Care
Local Government
United States
United States. Department of Health and Human Services

1543. Racial and ethnic health disparities

Publication:

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

Subject(s):

Healthcare Disparities
Systemic Racism
United States

1544. Black Lung benefits program: continued inaction on coal operator self-insurance increases financial risk to trust fund : testimony before the Committee on Education and Labor, Subcommittee on Workforce Protections, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, December 2, 2021

Subject(s):

Anthracosis -- economics
Government Regulation
Insurance, Health -- legislation & jurisprudence
United States

1545. Social Security Administration: Actions needed by SSA to ensure disability medical consultants are properly screened and trained : report to the Committee on Ways and Means, Subcommittee on Social Security, House of Representatives

Publication:

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

Subject(s):

COVID-19 Vaccines -- supply & distribution
Government Regulation
Stakeholder Participation
United States
United States. Department of Health and Human Services

1546. Drug development: Pathway for approving antibacterial and antifungal drugs for patients with limited treatment options is infrequently used : report to congressional committees

Publication:

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

Subject(s):

Drug Development -- legislation & jurisprudence
Drug Resistance
Government Regulation
Legislation, Drug -- organization & administration
United States
United States. Food and Drug Administration

1547. Rare diseases: Although limited, available evidence suggests medical and other costs can be substantial : report to congressional committees

Publication:

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

Subject(s):

Government Regulation
Rare Diseases -- economics
United States

1548. 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

1549. Opioid use disorder: opportunities to improve assessments of State Opioid Response grant program : report to congressional requesters

Publication:

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

Subject(s):

Data Interpretation, Statistical
Financing, Government -- organization & administration
Government Regulation
Opioid-Related Disorders -- economics
United States
United States. Substance Abuse and Mental Health Services Administration

1550. Cybersecurity: NIH needs to take further actions to resolve control deficiencies and improve its program : report to congressional requesters

Publication:

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

Subject(s):

Computer Security -- legislation & jurisprudence
Government Regulation
United States
National Institutes of Health (U.S.)