Search

701. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, October 2020

Subject(s):

Drug Industry
Drug and Narcotic Control
Pharmaceutical Preparations
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

702. 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

703. Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, October 28, 2020

Subject(s):

Defibrillators
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

704. Investigational COVID-19 convalescent plasma

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, February 11, 2021

Subject(s):

Antibodies, Viral
Blood Donors
COVID-19 -- therapy
Plasma
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

705. Certificates of confidentiality: guidance for sponsors, sponsor-investigators, researchers, industry, and food and drug administration staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research September 2020

Subject(s):

Biomedical Research
Confidentiality
Privacy
Research Subjects
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

706. Control of nitrosamine impurities in human drugs

Publication:

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

Subject(s):

Drug Contamination -- prevention & control
Nitrosamines
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

707. Resuming normal drug and biologics manufacturing operations during the COVID-19 public health emergency

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, September 2020

Subject(s):

Biological Products
Drug Industry
Manufacturing and Industrial Facilities
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

708. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2020

Subject(s):

Clinical Trials as Topic
COVID-19 Drug Treatment
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

709. ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2020

Subject(s):

Drug Approval
Drug Industry
Drugs, Generic
Therapeutic Equivalency
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

710. Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2020

Subject(s):

Biological Products
Drug Labeling
Prescription Drugs
Counterfeit Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

711. Recognition and withdrawal of voluntary consensus standards: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2020

Subject(s):

Consensus
Equipment and Supplies -- standards
Voluntary Programs -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

712. The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020

Subject(s):

Accreditation
Equipment and Supplies
Materials Testing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

713. Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020

Subject(s):

Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

714. Biocompatibility testing of medical devices: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020

Subject(s):

Accreditation
Equipment and Supplies
Materials Testing -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

715. Blood glucose monitoring test systems for prescription point-of-care use: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020

Subject(s):

Blood Glucose
Equipment Safety
Point-of-Care Testing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

716. Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020

Subject(s):

Breast Implants
Equipment Safety
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

717. Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020

Subject(s):

Blood Glucose Self-Monitoring
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

718. Use of International Standard ISO 10993-1: "Biological evaluation of medical devices - part 1 : evaluation and testing within a risk management process" : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020

Subject(s):

Device Approval
Equipment Failure
Equipment Safety
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

719. Eosinophilic esophagitis: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2020

Subject(s):

Drug Development
Eosinophilic Esophagitis -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

720. Putting people first by strengthening Medicare for the future: promising payment and delivery system innovations in Medicare

Author(s):

Komisar, Harriet, author
Lind, Keith, author
Noel-Miller, Claire, author

Publication:

Washington, DC : AARP Public Policy Institute, October 2020

Subject(s):

Insurance, Health, Reimbursement
Medicare
Reimbursement Mechanisms
Delivery of Health Care -- economics
United States

721. How unaffordability of nongroup health insurance threatens the health security of older adults

Author(s):

Sung, Jane, author
Dean, Olivia, author
Saavoss, Asha, author
Koenig, Land, author

Publication:

Washington, DC : AARP Public Policy Institute, November 2020

Subject(s):

Aged
Insurance Coverage -- economics
Insurance Coverage -- statistics & numerical data
Middle Aged
United States

722. Caring locally for caregivers: how state and local laws protect family caregivers from discrimination at work

Author(s):

Calvert, Cynthia Thomas, author
Lee, Jessica, (Travel writer) author

Publication:

Washington, DC : AARP Public Policy Institute, February 2021

Subject(s):

Caregivers -- legislation & jurisprudence
Employment -- legislation & jurisprudence
Local Government
State Government
United States

723. The effects of Medicaid expansion under the ACA: updated findings from a literature review

Author(s):

Madeline, Guth, author
Garfield, Rachel, author
Rudowitz, Robin, author

Publication:

San Francisco, CA : Henry J. Kaiser Family Foundation, March 2020

Subject(s):

Insurance Coverage -- statistics & numerical data
Medicaid -- statistics & numerical data
Health Services Accessibility -- statistics & numerical data
Medicaid -- economics
United States
United States.

724. Medicaid and CHIP eligibility, enrollment, and cost sharing policies as of January 2020: findings from a 50-state survey

Author(s):

Brooks, Tricia, author
Roygardner, Lauren, author
Artiga, Samantha, author
Pham, Olivia, author
Dolan, Rachel, author

Publication:

San Francisco, CA : Henry J. Kaiser Family Foundation, March 2020

Subject(s):

Cost Sharing
Eligibility Determination
Insurance Coverage -- statistics & numerical data
Medicaid -- statistics & numerical data
State Government
United States
United States.
State Children's Health Insurance Program (U.S.)

725. How state Medicaid programs are managing prescription drug costs: results from a state Medicaid pharmacy survey for state fiscal years 2019 and 2020

Author(s):

Gifford, Kathleen, author
Winter, Anne, author
Wiant, Linda, author
Dolan, Rachel, author
Tian, Marina, author
Garfield, Rachel, author

Publication:

San Francisco, CA : Henry J. Kaiser Family Foundation, April 2020

Subject(s):

Cost Control
Drug Costs
Medicaid
State Government
United States

726. Options to make Medicare more affordable for beneficiaries amid the COVID-19 pandemic and beyond

Author(s):

Cubanski, Juliette, author
Freed, Meredith, author
Neuman, Tricia, author
Damico, Anthony, author

Publication:

San Francisco, CA : Henry J. Kaiser Family Foundation, December 2020

Subject(s):

COVID-19
Financing, Personal
Medicare -- economics
United States

727. Digital health technologies as an adjunct to medication assisted therapy for opioid use disorder: final evidence report and meeting summary

Author(s):

Tice, Jeffrey A., author
Whittington, Melanie D., author
Fluetsch, Noemi, author
Zapata, Lorenzo Villa, author
Mendola, Nicolas D., author
Chapman, Rick M., author
Campbell, Jonathan D., author
Pearson, Steven D., author
Bradt, Pamela, author

Publication:

[Boston, Massachusetts] : Institute for Clinical and Economic Review, December 11, 2020

Subject(s):

Behavior Therapy
Digital Technology
Opiate Substitution Treatment
Opioid-Related Disorders -- therapy
United States

728. Supervised injection facilities and other supervised consumption sites: effectiveness and value : final report

Author(s):

Armbrecht, Eric, author
Guzauskas, Greg, author
Hansen, Ryan, author
Pandey, Rajshree, author
Fazioli, Katherine, author
Chapman, Rick M., author
Pearson, Steven D., author
Rind, David M., author

Publication:

[Boston, Massachusetts] : Institute for Clinical and Economic Review, January 8, 2021

Subject(s):

Harm Reduction
Needle-Exchange Programs
Opiate Overdose -- prevention & control
Opioid-Related Disorders -- therapy
United States

729. Unsupported price increase report: 2020 assessment

Author(s):

Rind, David M., author
Agboola, Foluso, author
Chapman, Richard, author
Borrelli, Eric, author
McKenna, Avery, author
Pearson, Steven D., author

Publication:

[Boston, Massachusetts] : Institute for Clinical and Economic Review, January 12, 2021

Subject(s):

Drug Costs -- statistics & numerical data
Health Expenditures -- statistics & numerical data
United States

730. Nadofaragene firadenovec and oportuzumab monatox for BCG-unresponsive, non-muscle invasive bladder cancer: effectiveness and value : final report

Author(s):

Atlas, Steven J., author
Touchette, Daniel R., author
Beinfeld, Molly, author
McKenna, Avery, author
Joshi, Mrinmayee, author
Chapman, Rick M., author
Pearson, Steven D., author
Rind, David M., author

Publication:

[Boston, Massachusetts] : Institute for Clinical and Economic Review, January 15, 2021

Subject(s):

Antibodies, Monoclonal -- therapeutic use
Urinary Bladder Neoplasms -- drug therapy
Genetic Vectors -- therapeutic use
United States

731. Mental health and primary care networks: understanding the opportunities

Author(s):

Naylor, Chris, author
Bell, Andy, author
Baird, Beccy, author
Heller, Abigail, author
Gilbert, Helen, author

Publication:

[London, England] : The King's Fund, July 2020

Subject(s):

Community Mental Health Services
Primary Health Care
United Kingdom

732. Technology and innovation for long-term health conditions

Author(s):

Collins, Ben, author

Publication:

[London, England] : The King's Fund, August 2020

Subject(s):

Diabetes Mellitus, Type 1 -- therapy
Digital Technology
Electronic Health Records
Mobile Applications
Pulmonary Disease, Chronic Obstructive -- therapy
Social Support
Telemetry
United Kingdom

733. The courage of compassion: supporting nurses and midwives to deliver high-quality care

Author(s):

West, Michael, author
Bailey, Suzie, author
Williams, Ethan, author

Publication:

[London, England] : The King's Fund, September 2020

Subject(s):

Burnout, Professional -- prevention & control
Midwifery
Nurse Midwives
Quality of Health Care
United Kingdom

734. Patient Safety Authority: 2020 annual report

Publication:

Harrisburg, PA : Pennsylvania Patient Safety Authority, [2021]

Subject(s):

Delivery of Health Care -- organization & administration
Patient Safety
Pennsylvania
United States

735. Hospital admissions for influenza and associated costs

Publication:

Harrisburg, PA : Pennsylvania Health Care Cost Containment Council, March 2019

Subject(s):

Hospitalization -- statistics & numerical data
Influenza, Human -- economics
Hospitalization -- economics
Pennsylvania
United States

736. Pediatric and congenital heart surgery: 2014-2017 data

Publication:

Harrisburg, PA : Pennsylvania Health Care Cost Containment Council, June 2019

Subject(s):

Heart Defects, Congenital -- surgery
Heart Defects, Congenital -- mortality
Outcome Assessment, Health Care
Pennsylvania
United States

737. Potentially preventable hospitalizations in Pennsylvania

Publication:

Harrisburg, PA : Pennsylvania Health Care Cost Containment Council, June 2020

Subject(s):

Hospitalization -- statistics & numerical data
Primary Prevention
Pennsylvania
United States

738. Financial analysis 2019: an annual report on the financial health of Pennsylvania non-GAC hospitals. Volume three, Rehabilitation, psychiatric, long-term acute care, specialty

Publication:

Harrisburg, PA : Pennsylvania Health Care Cost Containment Council, December 2020

Subject(s):

Economics, Hospital -- statistics & numerical data
Hospitals, Special -- economics
Pennsylvania
United States

739. Medicaid long-term services and supports: access and quality problems in managed care demand improved oversight : report to the chairman, Committee on Energy and Commerce, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, November 2020

Subject(s):

Government Regulation
Managed Care Programs
Medicaid -- organization & administration
Government Agencies -- standards
United States
Centers for Medicare & Medicaid Services (U.S.)

740. Medicaid eligibility: accuracy of determinations and efforts to recoup federal funds due to errors : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, January 2020

Subject(s):

Eligibility Determination
Financial Audit
Government Regulation
Medicaid -- economics
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

741. Social Security disability: action needed to help agency staff understand and follow policies related to prescription opioid misuse : report to the Subcommittee on Social Security, Committee on Ways and Means, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, January 2020

Subject(s):

Insurance, Disability
Opioid-Related Disorders
Prescription Drug Misuse
Government Regulation
United States
United States. Social Security Administration

742. Insanitary conditions at compounding facilities

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, November 2020

Subject(s):

Drug Compounding
Drug Industry -- standards
Facility Regulation and Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

743. Nonclinical testing of orally inhaled nicotine-containing drug products

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, October 2020

Subject(s):

Administration, Inhalation
Tobacco Use Cessation Devices
Toxicity Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

744. Referencing approved drug products in ANDA submissions

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, October 2020

Subject(s):

Drug Approval
Drugs, Generic
Reference Books, Medical
Therapeutic Equivalency
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

745. Indian Health Service: actions needed to improve oversight of federal facilities' decision-making about the use of funds : report to Congressional addressees

Publication:

Washington, DC : United States Government Accountability Office, November 2020

Subject(s):

American Indian or Alaska Native
Government Regulation
Health Facility Administration
United States
United States. Indian Health Service

746. Medicaid eligibility: accurate beneficiary enrollment requires improvements in oversight, data, and collaboration : testimony before the Subcommittee on Health Care, Committee on Finance, U.S. Senate

Publication:

Washington, DC : United States Government Accountability Office, October 30, 2019

Subject(s):

Eligibility Determination
Government Regulation
Medicaid -- economics
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

747. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021

Subject(s):

Clinical Trial Protocols as Topic
Clinical Trials as Topic -- methods
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

748. Financial analysis 2019: an annual report on the financial health of Pennsylvania hospitals. Volume one, General acute care hospitals

Publication:

Harrisburg, PA : Pennsylvania Health Care Cost Containment Council, April 2020

Subject(s):

Economics, Hospital -- statistics & numerical data
Hospitals, General -- economics
Hospitals, General -- statistics & numerical data
Pennsylvania
United States

749. Notifying CDRH of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act during the 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, November 2020

Subject(s):

Equipment and Supplies
Manufacturing Industry
Medical Device Legislation
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

750. VA acquisition management: actions needed to improve management of medical-surgical prime vendor program and inform future decisions : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, September 2020

Subject(s):

Equipment and Supplies -- economics
Government Regulation
Veterans
United States
United States. Department of Veterans Affairs

751. Qualification process for drug development tools: guidance for industry and FDA staff

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, November 2020

Subject(s):

Drug Approval
Drug Development -- methods
Drug Development -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

752. Formal meetings between FDA and ANDA applicants of complex products under GDUFA

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, November 2020

Subject(s):

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

753. VA health care: actions needed to ensure provider qualifications and competence : testimony before the Subcommittee on Oversight and Investigations, Committee on Veterans' Affairs, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, October 2019

Subject(s):

Credentialing
Facility Regulation and Control
Government Regulation
Veterans -- legislation & jurisprudence
United States
United States. Department of Veterans Affairs

754. Regulatory considerations for microneedling products: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, November 10, 2020

Subject(s):

Medical Device Legislation
Needles -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

755. Enhancing the diversity of clinical trial populations: eligibility criteria, enrollment practices, and trial designs

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, November 2020

Subject(s):

Biological Variation, Population
Clinical Trial Protocols as Topic
Clinical Trials as Topic
Population Characteristics
Cultural Diversity
Genetic Variation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

756. Assessing user fees under the prescription drug user fee amendments of 2017

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, November 2020

Subject(s):

Drug Approval
Prescription Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

757. Medicaid demonstrations: actions needed to address weaknesses in oversight of costs to administer work requirements : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, October 2019

Subject(s):

Employment -- legislation & jurisprudence
Government Regulation
Medicaid -- legislation & jurisprudence
United States

758. Workforce Innovation And Opportunity Act: additional DOL actions needed to help states and employers address substance use disorder : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, May 2020

Subject(s):

Financing, Government -- organization & administration
Government Regulation
Opioid-Related Disorders -- economics
Workforce -- legislation & jurisprudence
United States
United States. Department of Labor

759. Indian Health Service: actions needed to improve oversight of provider misconduct and substandard performance : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, December 2020

Subject(s):

Government Regulation
Professional Misconduct -- legislation & jurisprudence
Work Performance -- standards
United States
United States. Indian Health Service

760. VA health care: actions needed to improve oversight of graduate medical education reimbursement

Publication:

Washington, DC : United States Government Accountability Office, July 2020

Subject(s):

Education, Medical, Graduate -- economics
Government Regulation
Reimbursement Mechanisms
United States
United States. Department of Veterans Affairs

761. Indian Health Service: actions needed to improve oversight of federal facilities' decision-making about the use of funds : report to Congressional addressees

Publication:

Washington, DC : United States Government Accountability Office, November 2020

Subject(s):

American Indian or Alaska Native -- legislation & jurisprudence
Government Regulation
Health Facility Administration -- economics
United States
United States. Indian Health Service

762. Controlled correspondence related to generic drug development

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, December 2020

Subject(s):

Correspondence as Topic
Drug Development
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

763. Spinal plating systems: 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, December 11, 2020

Subject(s):

Bone Plates
Equipment Design
Equipment Safety
Spinal Cord
Spinal Fusion
Materials Testing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

764. VA health care: better data needed to assess the health outcomes of lesbian, gay, bisexual, and transgender veterans : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, October 2020

Subject(s):

Health Equity
Outcome Assessment, Health Care
Sexual and Gender Minorities -- statistics & numerical data
Veterans -- statistics & numerical data
Veterans Health Services -- statistics & numerical data
Routinely Collected Health Data
United States
United States. Department of Veterans Affairs

765. Opioid use disorder: barriers to Medicaid beneficiaries' access to treatment medications : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, January 2020

Subject(s):

Analgesics, Opioid -- supply & distribution
Analgesics, Opioid -- therapeutic use
Health Services Accessibility
Medicaid -- economics
Opiate Substitution Treatment
Opioid-Related Disorders -- drug therapy
United States
Centers for Medicare & Medicaid Services (U.S.)

766. FDA drug approval: application review times largely reflect FDA goals : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, March 2020

Subject(s):

Investigational New Drug Application -- organization & administration
Time Factors
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

767. FDA drug approval: application review times largely reflect agency goals : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, March 2020

Subject(s):

Investigational New Drug Application -- organization & administration
Time Factors
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

768. Medicare and Medicaid: alignment of managed care plans for dual-eligible beneficiaries : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, March 2020

Subject(s):

Dual MEDICAID MEDICARE Eligibility
Government Regulation
Managed Care Programs
United States
Centers for Medicare & Medicaid Services (U.S.)

769. Veterans health care: agency efforts to provide and study prosthetics for small but growing female veteran population : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, November 2020

Subject(s):

Prostheses and Implants
Veterans
Women's Health
United States
United States. Department of Veterans Affairs

770. Two proposals to strengthen paid-leave programs: invest in return-to-work services and test a longer benefit

Author(s):

Smalligan, Jack, author
Boyens, Chantel, author

Publication:

Washington, DC : Urban Institute, January 2020

Subject(s):

Family Leave
Return to Work
Sick Leave
United States

771. Southwest border: CBP should improve oversight of funds, medical care, and reporting of deaths : testimony before the Committee on Homeland Security, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, July 2020

Subject(s):

Delivery of Health Care
Financing, Government
Government Regulation
Jails
Undocumented Immigrants
Mortality
United States

772. Southwest border: CBP needs to increase oversight of funds, medical care, and reporting of deaths : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, July 2020

Subject(s):

Delivery of Health Care
Financing, Government
Government Regulation
Jails
Undocumented Immigrants
Mortality
United States

773. Orthopedic non-spinal metallic bone screws and washers: 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, December 11, 2020

Subject(s):

Bone Screws
Equipment Safety
Orthopedic Equipment
Orthopedic Fixation Devices
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

774. Magnetic resonance (MR) receive-only coil: 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, December 11, 2020

Subject(s):

Equipment Safety
Magnetic Resonance Imaging
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

775. Immigration detention: care of pregnant women in DHS facilities : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, March 2020

Subject(s):

Jails -- organization & administration
Pregnant People
Prenatal Care
Undocumented Immigrants
Pregnancy Outcome
United States
United States. Department of Homeland Security

776. COVID-19: brief update on initial federal response to the pandemic : report to Congress

Publication:

Washington, DC : United States Government Accountability Office, August 2020

Subject(s):

COVID-19 -- economics
Financing, Government -- organization & administration
Government Regulation
Health Status Indicators
United States

777. Nursing homes: better oversight needed to protect residents from abuse : statement for the record to the Committee on Ways and Means, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, November 2019

Subject(s):

Elder Abuse
Government Regulation
Nursing Homes -- legislation & jurisprudence
United States
Centers for Medicare & Medicaid Services (U.S.)

778. Best practices in developing proprietary names for human prescription drug products

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, December 2020

Subject(s):

Drug Labeling
Medication Errors -- prevention & control
Prescription Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

779. Requesting FDA feedback on combination products: guidance for industry and FDA staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, December 2020

Subject(s):

Biological Products
Formative Feedback
Legislation, Drug
Medical Device Legislation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

780. Drug misuse: agencies have not fully identified how grants that can support drug prevention education programs contribute to national goals : report to Congress

Publication:

Washington, DC : United States Government Accountability Office, November 2020

Subject(s):

Health Education
Program Evaluation
School Health Services
Substance-Related Disorders -- prevention & control
Federal Government
United States
United States. Department of Health and Human Services

781. Rural hospital closures: affected residents had reduced access to health care services : report to the ranking member, Committee on Homeland Security and Governmental Affairs, United States Senate

Publication:

Washington, DC : United States Government Accountability Office, December 2020

Subject(s):

Health Facility Closure
Health Services Accessibility
Hospitals, Rural -- suply & distribution
Rural Health Services -- supply & distribution
United States
United States. Department of Health and Human Services

782. VA health care: additional training could improve organ transplant referral and evaluation processes : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, 2019 October

Subject(s):

Organ Transplantation
Referral and Consultation -- organization & administration
Veterans
Waiting Lists
United States
United States. Department of Veterans Affairs

783. VA health care: additional steps could help improve Community care budget estimates : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, September 2020

Subject(s):

Budgets
Community Health Services -- economics
Government Regulation
United States
United States. Department of Veterans Affairs

784. Defense health care: additional information and monitoring needed to better position DOD for restructuring medical treatment facilities : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, May 2020

Subject(s):

Government Regulation
Health Facilities -- economics
Military Health Services -- supply & distribution
United States
United States. Department of Defense

785. Antibiotic resistance: additional federal actions needed to better determine magnitude and reduce impact

Publication:

Washington, DC : United States Government Accountability Office, March 2020

Subject(s):

Bacterial Infections -- therapy
Drug Resistance, Bacterial
Diagnostic Techniques and Procedures
Epidemiological Monitoring
Government Regulation
United States
Centers for Disease Control and Prevention (U.S.)

786. National biodefense strategy: additional efforts would enhance likelihood of effective implementation : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, February 2020

Subject(s):

Biological Warfare -- prevention & control
Bioterrorism -- prevention & control
Civil Defense
Crop Protection
Disease Outbreaks -- prevention & control
Government Regulation
Risk Management
United States

787. Science and tech spotlight: e-cirgarettes

Publication:

[Washington, DC] : United States Government Accountability Office, June 2020

Subject(s):

Electronic Nicotine Delivery Systems
Vaping -- adverse effects
United States

788. Defense health care: DOD surveys indicate beneficiary experience generally unchanged in first year of TRICARE select : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, February 2020

Subject(s):

Health Benefit Plans, Employee
Health Services Accessibility
Military Personnel
Managed Care Programs
Patient Satisfaction
United States
United States. Department of Defense

789. Preventing drug diversion: disposal of controlled substances in home hospice settings : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, April 2020

Subject(s):

Controlled Substances
Drug and Narcotic Control -- organization & administration
Hospice Care
Prescription Drug Diversion
United States

790. Anesthesia services: differences between private and Medicare payments likely due to providers' strong negotiating position : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, October 2020

Subject(s):

Anesthesia -- economics
Medicare -- economics
United States
Centers for Medicare & Medicaid Services (U.S.)

791. Science and tech spotlight: COVID-19 vaccine development

Publication:

[Washington, DC] : United States Government Accountability Office, May 2020

Subject(s):

COVID-19 Vaccines -- therapeutic use
Drug Development
United States

792. Science and tech spotlight: COVID-19 testing

Publication:

[Washington, DC] : United States Government Accountability Office, May 2020

Subject(s):

COVID-19 Testing -- methods
United States
United States. Food and Drug Administration

793. Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol, including during the public health emergency (COVID-19)

Publication:

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

Subject(s):

2-Propanol
Drug Compounding
Ethanol
Methanol
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

794. Protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 public health emergency

Publication:

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

Subject(s):

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

795. COVID-19: potency assay considerations for monoclonal antibodies and other therapeutic proteins targeting SARS-CoV-2 infectivity

Publication:

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

Subject(s):

Antibodies, Monoclonal
COVID-19 Drug Treatment
Enzyme-Linked Immunosorbent Assay
SARS-CoV-2
Viral Plaque Assay
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

796. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021

Subject(s):

Device Approval
Formative Feedback
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

797. Safer technologies program for medical devices: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021

Subject(s):

Device Approval
Equipment Safety
Voluntary Programs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

798. Mouse embryo assay for assisted reproduction technology devices: guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, January 5, 2021

Subject(s):

Biological Assay
Device Approval
Embryo, Mammalian
Mice
Reproductive Techniques, Assisted
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

799. Consumer Antiseptic Rub Final Rule: questions and answers : small entity compliance guide

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, December 2020

Subject(s):

Hand Sanitizers -- chemistry
Hand Sanitizers -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

800. Effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices: questions and answers (revised) : guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, June 2020

Subject(s):

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