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611. Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Data Collection
Digital Health
Equipment Design
Equipment Safety
Government Regulation
Medical Device Legislation
Remote Sensing Technology -- standards
United States

612. Rare diseases: considerations for the development of drugs and biological products : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Biological Products
Drug Development
Drug Industry
Government Regulation
Rare Diseases -- drug therapy
United States

613. Development of monoclonal antibody products targeting SARS-CoV-2 for emergency use authorization: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Antibodies, Monoclonal
COVID-19 Drug Treatment
Drug Approval
Drug Industry
Government Regulation
Legislation, Drug
SARS-CoV-2
United States

614. Registration and listing of cosmetic product facilities and products: guidance for industry

Publication:: Silver Spring, MD : Office of the Chief Scientist, December 2023
Subject(s):: Cosmetics -- legislation & jurisprudence
Drug Industry
Government Regulation
Legislation, Drug
Manufacturing and Industrial Facilities -- legislation & jurisprudence
United States

615. Review of personnel shortages in federal health care programs during the COVID-19 pandemic

Publication:: Washington, D.C. : Pandemic Response Accountability Committee, September 2023
Subject(s):: COVID-19 -- economics
Government Programs
Government Regulation
Health Workforce -- statistics & numerical data
United States
United States. Department of Defense
United States. Department of Health and Human Services
United States. Department of Justice
United States. Department of Veterans Affairs

616. Georgia could better ensure that nursing homes comply with federal requirements for life safety, emergency preparedness, and infection control

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):: Disaster Planning -- standards
Government Regulation
Infection Control -- standards
Nursing Homes -- legislation & jurisprudence
Nursing Homes -- standards
Safety Management -- standards
Georgia

617. CDC’S Vaccines for Children program recipients did not conduct site visits at some providers as required

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):: Child Health
Government Programs
Government Regulation
Immunization Programs
Vaccines -- supply & distribution
United States
Centers for Disease Control and Prevention (U.S.)
Vaccines for Children (Program)

618. Key strategies that states used for managing Medicaid and marketplace enrollment during the COVID-19 PHE

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):: COVID-19
Eligibility Determination -- organization & administration
Government Regulation
Health Insurance Exchanges
Medicaid -- organization & administration
State Health Planning and Development Agencies
United States

619. New York did not ensure that a managed care organization complied with requirements for denying prior authorization requests

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):: Government Regulation
Managed Care Programs -- legislation & jurisprudence
Medicaid -- legislation & jurisprudence
Medicaid -- organization & administration
Prior Authorization -- economics
New York

620. The Provider Relief Fund helped select nursing homes maintain services during the COVID-19 pandemic, but some found guidance difficult to use

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, December 2023
Subject(s):: Costs and Cost Analysis
COVID-19 -- economics
Government Programs
Government Regulation
Nursing Homes -- economics
Nursing Homes -- organization & administration
United States
United States. Department of Health and Human Services

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